RIT with 90Y Ibritumomab Tiuxetan in Agressive Non-Hodgkin Lymphoma. Evaluation of Recent Outcomes in a Single Institution

Abstract Abstract 4883 Diffuse Large B Cell (DLBC) and Mantle Cell Lymphoma (MCL), are two subtypes of aggressive non-Hodgkin lymphoma (A-NHL),that frequently present as advanced systemic disease limiting the use of involved field radiation. They are also predominant in advanced age population non suitable for intensive therapy such as stem cell transplantation. Their aggressive systemic behavior, confer high rates of relapse and short overall survival. The development of radioimmunotherapy brings a new therapeutic approach for both types of A-NHL. We present the results derived from a single-institute use of 90Y-Ibritumomab Tiuxetan (90Y-IT) (Zevalin®) in DLBC and MCL, both as consolidation therapy in first complete response (C-1CR) after chemoimmunotherapy and as second line treatment in relapsed disease (RD). Patients and Methods: we included 19 patients with A-NHL, 10 MCL and 9 DLBCL, treated with 90Y-IT according to a multidisciplinary clinical protocol, between September 2005 and February 2012. Inclusion criteria were: histological confirmed CD20+ MCL or DLBCL, with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, absolute platelet count (APC) ≥ 100 × 109/L, ≤ 25% bone marrow CD20+ lymphocytes, in Complete Remission (CR) after first line chemoimmunotherapy or with relapsed disease. All patients received two prior 250 mg/m2 Rituximab doses, followed by 0.4 mCi /kg IV 90Y-IT. Response was evaluated by PET/TC 12 weeks after treatment. Major endpoints were: objective response rate (ORR), overall survival (OS), progression free survival (PFS), and safety. Other clinical prognostic factors were taken into account upon their possible influence in treatment value. Results: 18 of 19 patients treated with 90Y-IT completed follow-up and were taken into analysis, 10 MCL (52.6%) and 9 DLBCL (47.4%); M/F distribution 10/9 (73.6/26.4%); Overall ECOG 0–1 82.35%. Mean follow-up time: 46.8 months. 8 patients were treated as C-1CR, 4 MCL and 4 DLBCL. For MCL mean age was 66.9 (53–79) years. MIPI score distribution: 0–3 (70.0%), >3 (30.0%). Status before 90Y-IT was: C-1CR 3; relapsed in CR after chemotherapy 3; relapsed/refractory with active disease after chemotherapy (PR) 4. Previous chemotherapeutic schedules: ≤2 (50 %). Overall response (80.0%) 7 CR; 1 PR. Mean estimated OS since 90Y-IT: 57.0 months (52.4–61.6), median OS: 59 months (34.8–86.1) and mean PFS: 24.9 months (95% CI: 14.3–35.6); median PFS: 22 months (95% CI: 1.9–42.0). For DLBCL: mean age 53 (35–87) years. IPI-R score distribution: 0–2 (33.3%), >2 (66.7%). Status before 90Y-IT was: C-1CR 5; relapse/refractory with active disease after chemotherapy (PR) 4; Previous chemotherapeutic schedules ≤2 (77.8%). Overall responses (88.8%) 5 CR; 3 PR. Mean OS since 90Y-IT: 49.2 months (42.8–55.6); median OS: NR and mean PFS: 39 months (95% CI: 22.6–55.4). Until analysis 11 patients have relapsed (57.8%), 8 MCL (80%) and 3 DLBCL (37.5%). Four patients had died, 3 because of disease progression even after several chemotherapeutic treatments. In respect to safety: thrombocytopenia was the most frequent hematologic toxicity presented in 63.1%, grade 3–4 in 21%, with median time to presentation of 2.8 weeks and median time for recovery of 3 weeks. Neutropenia occurred in 52.6%, grade 3–4 in 21%, with median time for recovery of 2 weeks. 1 patient (5.2%) required red cell transfusion and 4 (21.5%) needed platelet transfusion. The most frequent non hematologic toxicity was asthenia. One MCL patient who relapsed 28 months and received 2 more chemotherapy schedules has been diagnosed, four years after 90Y-IT as lung carcinoma. Conclusions: 90Y-IT is a safe and effective consolidation therapy in A-NHL, that allows sustained CR and extends PFS with a low toxicity profile. There are needed further studies to evaluate the impact of radioimmunotherapy in A-NHL. This worh has bee partially sponsored by a grant from FEHHA Disclosures: No relevant conflicts of interest to declare.

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RIT with Y90-Ibritumomab Tiuxetan in Follicular Non-Hodgkin Lymphoma: Evaluation of Recent Outcomes in a Single Institution

Journal of Oncology ◽

10.1155/2012/412742 ◽

2012 ◽

Vol 2012 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Marcio Miguel Andrade Campos ◽

Anel E. Montes Limón ◽

Jose María Grasa ◽

Paola Lievano ◽

Teresa Baringo ◽

...

Keyword(s):

Hodgkin Lymphoma ◽

Early Stage ◽

Therapy Outcomes ◽

Clinical Database ◽

Ibritumomab Tiuxetan ◽

Score Distribution ◽

Non Hodgkin Lymphoma ◽

Relapsed Disease ◽

Previous Disease

Background. Based on historical data we reviewed our hospital clinical database to analyse our updated information and therapy outcomes of follicular non-Hodgkin lymphoma (F-NHL) patients treated with90Y-Ibritumomab tiuxetan.Patients and Methods. Between 2005 and 2011, 56 F-NHL patients were included in a clinical protocol conducted by a multidisciplinary team and treated in the same centre. All patients received 0.3 or 0.4 mCi/kg IV (88%) of90Y-IT; response evaluation was performed 12 weeks after.Results. M/F 44.6%/55.4%, mean age 61.45 years (30–85); ECOG 0-1 96.9%. According to FLIPI score, distribution were good: 58.5%, intermediate: 29.2%, and poor: 12.3%. Previous therapies: >2: 40% (26). ORR was 94.6% (53/56). CR: 85.7%; CR according to previous disease: relapsed disease: 90% (27/30), refractory disease: 42.85% (3/7), consolidation with CR: 92.85% (13/14), and consolidation with PR: 100% (5/5). Global PR and NR were 8.9% (5) and 5.3% (3), respectively. Mean OS 63.86 months with a mean follow-up time of 57 months (2–73). Mean TTP: 52.65 months (95% CI: 43.83–61.48). Median OS and TTP were not achieved. No hospital submissions or deaths were registered.Conclusions. This study confirms the safety and high efficacy of90Y-IT in F-NHL patients, RIT in early stage of disease could improve outcomes.

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Modified Magrath IVAC Regimen as Second-Line Therapy for Relapsed and Refractory Aggressive Non-Hodgkin Lymphoma in Developing Countries: The Experience of a Single Center in Brazil.

Blood ◽

10.1182/blood.v104.11.4588.4588 ◽

2004 ◽

Vol 104 (11) ◽

pp. 4588-4588

Author(s):

Luis F. Pracchia ◽

Juliana Pereira ◽

Marcelo Belesso ◽

Beatriz Beitler ◽

Dalton A. Chamone

Keyword(s):

Hodgkin Lymphoma ◽

Median Overall Survival ◽

Overall Response Rate ◽

International Prognostic Index ◽

Prognostic Index ◽

B Cell Lymphoma ◽

Non Hodgkin Lymphoma ◽

Grade 3 ◽

Relapsed Disease

Abstract In this retrospective study we described the response and toxicity of a modified Magrath IVAC (mIVAC) regimen in 25 patients with refractory/relapsed aggressive non-Hodgkin lymphoma (NHL). The mIVAC consisted of ifosfamide 1,500mg/m2 (one-hour infusion beginning at 9:00; D1 to D5), mesna 300mg/m2 (bolus at hours 9:00, 13:00, 17:00; D1 to D5), citarabine 2,000 mg/m2 (two one-hour infusions beginning at 8:00 and 16:00; D1 and D2) and etoposide 60 mg/m2 (one-hour infusion beginning at 10:00; D1 to D5). Treatment was repeated every four weeks for a maximum of six cycles. Patients who achieved partial remission or complete remission after at least three courses were offered autologous stem cell transplantation (ASCT), if eligible. The median age was 37 years (range 18 to 59 years). Twenty-two (88%) patients had diffuse large B-cell lymphoma, fourteen (56%) had relapsed disease and 10 (40%) were considered high-intermediate and high risk by age-adjusted International Prognostic Index. The overall response rate was 68% (95% CI: 46%–90%). A total of 64 cycles were given, with a median of three courses per patient. Grade 3/4 neutropenia was observed after 85,6% of the courses, and grade 3/4 thrombocytopenia was observed after 87,5% of the courses. Grade 3/4 neutropenic fever occurred after 28% of the courses. Non-hematologic toxic effects were rare, predominantly grade 1/2. No toxic deaths were observed. Fifteen (88%) of the 17 responding patients underwent ASCT. With a median follow-up of 14 months, the median overall survival time for mIVAC sensitive patients was 16 months. This regimen may be feasible for patient with relapsed and refractory aggressive NHL in countries with inadequate numbers of hospital beds.

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Long-Term Outcome of Patients with Marginal Zone Non-Hodgkin Lymphoma (MZL) Treated with Yttrium-90 Ibritumomab Tiuxetan: The Mayo Clinic Experience

Blood ◽

10.1182/blood-2019-130384 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1544-1544

Author(s):

Muhamad Alhaj Moustafa ◽

Ricardo Parrondo ◽

Gregory Wiseman ◽

Jennifer Peterson ◽

Thomas E. Witzig ◽

...

Keyword(s):

Median Time ◽

Research Funding ◽

Low Grade ◽

Ibritumomab Tiuxetan ◽

Term Outcome ◽

Long Term Outcome ◽

Grade 3 ◽

Yttrium 90

Background MZL is a low-grade non-Hodgkin's lymphoma (NHL) which involves lymph nodes, extranodal sites, or spleen. It is sensitive to radiation therapy, which is used in localized disease with curative intent. Yttrium-90 ibritumomab tiuxetan [(90)Y-IT; Zevalin] is a radio-immunoconjugate (RIC) that targets CD20. It is approved for relapsed/refractory low grade and follicular NHL. The data on its use in MZL is limited. We present long-term outcome of the largest reported cohort of MZL patients who received (90)Y-IT. Methods Medical records of patients who received treatment with (90)Y-IT at Mayo Clinic Cancer Center between January 2004 and December 2018 were analyzed. We selected patients with MZL and reviewed clinical data including age, gender, MZL type, clinical stage (Ann Arbor Staging System), treatment response, (90)Y-IT related adverse effects (AEs), as well as lymphoma and treatment related events. All patients received (90)Y-IT according to the standard treatment guidelines. Overall response rate (ORR) and complete response rate (CR) were calculated. Progression-free survival (PFS), time to next therapy (TTNT), and overall survival (OS) were analyzed using the Kaplan-Meier method. Results Twenty-one patients were identified (Table 1). The median age at diagnosis was 60 years (range, 11-81) and 71% (15/21) were female. 52% (11/21) were previously-untreated (UMZL) while 48% (10/21) were relapsed (RMZL). The median number of pretreatments in RMZL patients was 2 (range, 1-3). ECOG performance status at the time of treatment was 0 in 90% (19/21) and 1 in 10% (2/21). 62% (13/21) were stage III/IV disease at the time of (90)Y-IT therapy. The median follow-up was 8.5 years (95% CI; 4.5, 12.4); 17 (81%) patients remain alive. The ORR was 91% (19/21) with the two non-responders being in the RMZL group. The CR rate was 81% (17/21) and 65% (11/17) remain in CR at a median follow-up of 5.7 years (95% CI; 1.4, 11). Nine (43%) patients had a relapse during the study period. More relapses occurred in the RMZL group (7/10; 70%) compared to (2/11; 18%) in the UMZL group. Median PFS (whole cohort) was 10 years (95% CI; 2.1, NR) and TTNT (whole cohort) was not reached (NR) (95% CI; 2.1 years, NR). Median PFS was significantly higher in UMZL group compared to RMZL group NR (95% CI; 2.5 years, NR) vs 2.1 years (95% CI; 0.17, 9.9), respectively (Figure 1-A).Median OS (whole cohort) was 19.3 years (95% CI; 8.9, 19.3) without statistical difference in between UMZL group and RMZL group NR (95% CI; NR, NR) vs 16.6 years (95% CI; 9, 19.4), respectively (Figure 1-B). None of the 11 UMZL patients died at median follow up of 4.7 years (95% CI; 1.6, 9.2). All 4 deaths were in the RMZL group with 3 dying of transformation to high-grade lymphoma at 8, 22, and 25 months post-(90)Y-IT treatment. One patient died of myelodysplastic syndrome 7.3 years post-(90)Y-IT treatment while in CR. Toxicities were primarily hematologic. Grade ³3 neutropenia was observed in 6/21 (29%) patients with median time to nadir of 48.5 days (range, 19-70) and median time to recovery to normal absolute neutrophil count of 39.5 days (range, 7-476). Grade ³3 thrombocytopenia was observed in 3 (14%) patients with median time to nadir of 35 days (range, 19-357) and median time to recovery of 21 days (range, 2-538). Grade ³3 anemia was observed in only one patient. Only two patients required transfusions and growth factor support. Non-hematologic AEs included mild to severe fatigue in 4 patients. Conclusion RIC with (90)Y-IT is efficacious and well-tolerated in patients with previously untreated as well as relapsed MZL. As expected it appears to be more efficacious in previously untreated patients. Long-term complete remission (>5 years) was observed in 52% of the study population (43% of UMZL and 9% of RMZL). Combination of efficacy, tolerability, and treatment schedule most convenient for patients makes (90)Y-IT a reasonable alternative to systemic therapy with immunotherapy, chemotherapy, or chemo-immunotherapy in management of MZL. Figure 1: (A) Progression-free survival; comparing time to progression or death after (90)Y-IT treatment between previously untreated patients (UMZL) and patients with relapsed MZL (RMZL), (B) Overall survival; comparing time to death from all causes after (90)Y-IT treatment between UMZL patients and RMZL patients. Disclosures Tun: Curis: Research Funding; TG Therapeutics: Research Funding; BMS: Research Funding; DTRM Biopharma: Research Funding; Celgene: Research Funding; Mundi-pharma: Research Funding. OffLabel Disclosure: The use of Yttrium-90 ibritumomab tiuxetan as a first line treatment for marginal zone lymphoma

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Ixazomib-Lenalidomide-Dexamethasone (IRd) Consolidation Following Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Large Multi-Center Phase II Trial

Blood ◽

10.1182/blood-2018-99-109920 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 123-123 ◽

Cited By ~ 3

Author(s):

Ravi Vij ◽

Nitya Nathwani ◽

Thomas G. Martin ◽

Mark A. Fiala ◽

Abhinav Deol ◽

...

Keyword(s):

Board Of Directors ◽

Research Funding ◽

Response Rate ◽

Hematologic Toxicity ◽

Consolidation Therapy ◽

Newly Diagnosed ◽

Advisory Committees ◽

Oral Regimen ◽

Grade 3

Abstract Background: Maintenance therapy post-autologous stem cell transplantation (ASCT) has shown to improve progression-free and overall survival in multiple myeloma (MM) and has largely become the standard of care. Consolidation therapy, a brief duration of more-intensive chemotherapy administered prior to maintenance, has been shown to further deepen responses and may improve long-term outcomes. Ixazomib, lenalidomide and dexamethasone (IRd) is an all oral regimen that has been shown to be active in newly diagnosed MM as well as relapsed disease. In this study, we are analyzing the safety and efficacy of IRd as consolidation therapy after ASCT (NCT02253316). Methods: Eligible patients, age 18-70 with newly diagnosed MM undergoing ASCT during first-line treatment, are being consented prior to ASCT. Approximately 4 months following ASCT, patients receive 4 cycles of consolidation therapy with IRd [ixazomib 4 mg on days 1, 8 and 15 of a 28-day cycle, lenalidomide 15 mg on days 1 through 21, and dexamethasone 40 mg on days 1, 8 and 15]. The primary end point is minimal residual disease (MRD) status. MRD is being assessed by ClonoSEQ where possible and by multi-color flow where not. Toxicity, IMWG response rate, PFS, and OS are secondary end points. One month after the last consolidation cycle, patients are randomized (1:1) to maintenance therapy with single-agent ixazomib (4 mg on days 1, 8 and 15) or lenalidomide (15 mg daily). In total, 240 patients will be enrolled on the trial. This presentation coincides with planned interim analysis 2 which included data from the consolidation phase only. Results: As of July 2018, 172 patients with NDMM have been enrolled from 10 centers within the US. The median age was 57 (range 28-70) and 67% were male. 76% were white, 10% African-American/Black, and 13% were another race. 39% were ISS Stage I, 30% were Stage II, and 20% were Stage III. All patients received proteasome inhibitors and/or IMIDs as front-line induction and melphalan as conditioning for ASCT. IRd consolidation started at a median of 110 days post-ASCT (range 80-138). IRd has been well tolerated. Only 4% (6/154) of patients have been unable to complete the 4 cycles of consolidation to date due to toxicity. Grade 3 hematologic toxicity has been uncommon; 4% neutropenia, 3% thrombocytopenia, and 2% anemia. There has been no grade 4 hematologic toxicity. Non-hematologic grade 3-4 toxicities have included: infection (8%), nausea/vomiting/diarrhea (3%), and transaminitis (1%). No grade 3-4 peripheral neuropathy has been reported. One case of grade 5 pneumonia was reported but was not considered related to study treatment. Following ASCT, the MRD-negative rate was 26% and this improved to 37% following consolidation. In the subset of patients with Clonoseq results available, the MRD negative rate improved from 19% to 27%. Clinical response rate improved similarly; prior to consolidation the VGPR or better rate was 76% including 39% CR/sCR. Following consolidation, the VGPR or better rate was 85% including 56% CR/sCR. 137 patients went on to receive maintenance with either ixazomib (n = 71) or lenalidomide (n = 66). At time of submission, the median follow-up from start of IRd is 14 months and 28 patients have relapsed/progressed and 6 have expired. An interim analysis is planned for 2019, representing the first comparison of ixazomib and lenalidomide maintenance. Conclusion: IRd consolidation following ASCT appears to be safe and effective. The all oral regimen is convenient for patients which greatly simplifies follow-up in the peri-transplant period. Study enrollment is scheduled to complete in Q1 of 2019. Disclosures Vij: Karyopharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Jansson: Honoraria, Membership on an entity's Board of Directors or advisory committees. Martin:Amgen: Research Funding; Sanofi: Research Funding; Roche: Consultancy. Deol:Kite Pharmaceuticals: Consultancy; Novartis: Consultancy. Kaufman:Janssen: Consultancy; Karyopharm: Other: data monitoring committee; BMS: Consultancy; Abbvie: Consultancy; Roche: Consultancy. Hofmeister:Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Adaptive biotechnologies: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Research Funding. Gregory:Poseida Therapeutics, Inc.: Research Funding. Berdeja:Amgen: Research Funding; Celgene: Research Funding; Janssen: Research Funding; Takeda: Research Funding; Poseida Therapeutics, Inc.: Research Funding; Bristol-Myers Squibb: Research Funding; Bluebird: Research Funding; Genentech: Research Funding; Glenmark: Research Funding; Novartis: Research Funding; Teva: Research Funding; Sanofi: Research Funding. Chari:Pharmacyclics: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Array Biopharma: Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Consultancy; The Binding Site: Consultancy.

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Consolidation Therapy with Subcutaneous (SC) Alemtuzumab After Fludarabine and Rituximab (FR) Induction Therapy Improves the Complete Response (CR) Rate in Chronic Lymphocytic Leukemia (CLL) and Eradicates Minimal Residual Disease (MRD) but Is Associated with Severe Infectious Toxicity: Final Analysis of CALGB Study 10101.

Blood ◽

10.1182/blood.v114.22.210.210 ◽

2009 ◽

Vol 114 (22) ◽

pp. 210-210

Author(s):

Thomas S Lin ◽

Kathleen A Donohue ◽

John C. Byrd ◽

Margaret S Lucas ◽

Eva Hoke ◽

...

Keyword(s):

Residual Disease ◽

Progression Free Survival ◽

Final Analysis ◽

Complete Response ◽

Lymphocytic Leukemia ◽

Hematologic Toxicity ◽

Consolidation Therapy ◽

Varicella Zoster ◽

Grade 3

Abstract Abstract 210 Background: Alemtuzumab (Campath-1H) is approved for the treatment of CLL. CALGB sought to determine whether alemtuzumab can improve the CR rate and eradicate MRD after induction chemoimmunotherapy by performing a phase II study administering FR followed by alemtuzumab consolidation to previously untreated, symptomatic CLL patients (pts). We previously reported preliminary toxicity data (Lin et al. ASH 2007) and now report final toxicity and response data. Methods: Pts received fludarabine 25 mg/m2 IV on days 1–5, and rituximab 50 mg/m2 IV on day 1, 325 mg/m2 on day 3, and 375 mg/m2 on day 5 of cycle 1 and then only on day 1 of cycles 2–6, repeated every 28 days for up to 6 cycles. Four months after the last fludarabine dose, pts with stable (SD) or responsive disease by NCI 96 criteria received SC alemtuzumab 3 mg on day 1, 10 mg on day 3, and 30 mg on day 5, and then thrice weekly thereafter for 6 weeks (18 total doses). Pts received standard Pneumocystis (PCP) and Varicella zoster virus prophylaxis and were monitored weekly by PCR for Cytomegalovirus (CMV) viremia. When unacceptable serious infectious toxicity was noted in pts who received alemtuzumab after achieving CR from FR induction, the study was amended so that only PR or SD pts received alemtuzumab after FR. Results: Median age of pts (n=102) was 61 years (range, 23–82), 74% were male, and 30% were Rai stage III/IV. FR was well tolerated; 93% of pts received at least 3 cycles, and 77% completed all 6 cycles. Overall, complete and partial response (OR, CR, PR) rates after FR induction were 90%, 29% and 61%, and 15% were MRD negative by flow cytometry. Fifty-eight pts received alemtuzumab, and 42 (72%) completed the planned 6 weeks of therapy. OR, CR, and PR rates after alemtuzumab (n=58) were 91%, 66% and 26%, and 50% were MRD negative. Twenty-eight of 45 pts (62%) in PR after FR who received alemtuzumab attained CR. Of 11 pts in CR after FR who received alemtuzumab, 5 were MRD negative prior to consolidation and 3 of the other 6 converted to MRD negative afterwards. By intent-to-treat for all patients enrolled, OR, CR, and MRD negativity were attained by 90%, 57% and 42% of pts. With a median follow up of 34 months, median progression free survival (PFS) was 37 months (95% CI, 33–43 months); PFS was 73% and overall survival (OS) 86% at 2 years. Two-year PFS (76% vs 70%, p=0.54) and OS (84% vs 88%, p=0.89) were similar for pts who did and did not receive alemtuzumab. Similarly, there were no differences in PFS or OS among the 30 pts in CR after FR whether or not they received alemtuzumab, although the numbers were small. Grade 3–4 neutropenia and thrombocytopenia were observed in 43% and 19% of pts during alemtuzumab therapy. Grade 3–4 non-hematologic toxicity was observed in 41% of pts, including 19% infections and 19% febrile neutropenia, during alemtuzumab therapy. As we previously reported, 5 pts in CR after FR who received alemtuzumab died from infections (viral meningitis, Listeria meningitis, Legionella pneumonia, CMV and PCP pneumonia), and one pt in PR after FR who received alemtuzumab died of Epstein-Barr (EBV) viremia without evidence of EBV lymphoma. These grade 5 toxicities occurred both during and for up to 7 months after alemtuzumab therapy. Conclusions: Alemtuzumab consolidation improved the CR and MRD negative rates after FR induction. However, alemtuzumab consolidation resulted in significant toxicity, particularly severe infections in pts who achieved a CR after FR induction. Longer follow up is needed to determine if the improved CR and MRD negative rates following alemtuzumab consolidation will eventually result in improved PFS or OS, especially among pts who achieved a PR after FR induction. Disclosures: Lin: GlaxoSmithkline: Consultancy, Employment; Genentech: Consultancy; Bayer: Consultancy. Off Label Use: Use of alemtuzumab as consolidation therapy. Byrd:Genentech: Consultancy, Research Funding. Link:Genentech: Consultancy. Rai:Genentech: Consultancy; Bayer: Consultancy.

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90-Yttrium Ibritumomab Tiuxetan (Zevalin) and BEAM Chemotherapy (Z-BEAM) Vs BEAM for Autologous Stem Cell Transplantation in Lymphoma: Toxicity and Long Term Outcome From a Retrospective Multicentric Study of 123 Patients.

Blood ◽

10.1182/blood.v120.21.2726.2726 ◽

2012 ◽

Vol 120 (21) ◽

pp. 2726-2726

Author(s):

Louis Terriou ◽

Hanane Gasmi ◽

Salomon Manier ◽

Isabelle Plantier ◽

Marc Wetterwald ◽

...

Keyword(s):

Intensive Care Unit ◽

Stem Cell ◽

Intensive Care ◽

Stem Cell Transplantation ◽

Median Time ◽

Second Line ◽

First Line ◽

Ibritumomab Tiuxetan ◽

Grade 3

Abstract Abstract 2726 Background. There is a need for improving conditioning regimens in poor risk Non Hodgkin Lymphoma (NHL) patients (pts) eligible for autologous stem cell transplantation (ASCT). Incorporating radioimmunotherapy in the conditioning is an option. Bexxar-BEAM does not appear to be superior to BEAM in relapsed Diffuse Large B –cell lymphoma (DLBCL). The benefic risk ratio of 90-yttrium ibritumomab tiuxetan (Zevalin) BEAM remains to be established. Aims and methods. We analyzed retrospectively the efficacy and the toxicity of Zevalin combined with BEAM chemotherapy (Z-BEAM) compared with BEAM alone followed by ASCT. From January 2000 to November 2004 (BEAM group) and from June 2005 to December 2011 (Z-BEAM group), 55 and 68 pts respectively were treated in 6 French centers (male n=78, female n=45). Zevalin was administered on day-14 prior to ASCT with standard dose of 0.4 mci/kg (n=32) or 0.3 mci/kg (n=36) chosen according to bone marrow reserve. The efficacy and toxicity were compared between the two groups. Results. The study included 123 pts (median age: 53 years old; range 21–69) with different histological subtypes (58 DLBCL, 19 Mantle cell lymphomas, 37 follicular lymphoma, 3 marginal zone lymphoma, 4 MALT lymphoma and 2 B-lymphocytic lymphoma). Fifty-four pts were treated in first line (20 in the Z-BEAM group and 34 in the BEAM group) and 69 pts in second line (Z-BEAM, n=48; BEAM, n=21). The median time to platelets engraftment (>20000/mm3) was 9 days and 10 days in the Z-BEAM and BEAM group respectively (p=0.334), and the median time to neutrophil engraftment (>500/mm3) was 11 days and 12 days respectively (P=0.117). Grade 3/4 infectious events were more frequent in the Z-BEAM group (80.9%) than in the BEAM group (56.4%), p=0.0001. Grade 3/4 mucositis were observed in 42.6% in the Z-BEAM group Vs 12.7% in the BEAM group (p<0.0001). Admissions to intensive care unit were more frequent in the Z-BEAM group (20.6%) than in the BEAM group (7.3%), p=0.038. Transplant-related mortality (TRM) occurred in six (8.8%) patients in the Z-BEAM group and only one patient (1.8%) in the BEAM group (P=0.071). Median follow up was 73 months in the BEAM group (range 3.1–141 months) and 31 months in the Z-BEAM group (1.4–80.9 months). The 3-years OS is 80% (95%CI, 69–89%) and 78.1% (95%CI, 64.5–88%) in the Z-BEAM and the BEAM group respectively (P=0.864), and 3-years PFS was 65% (95%CI, 56–79%) and 63.4% (95%CI, 51–77%) respectively (P=0.539). Outcome was not statically different with Age (>60 y.o), histological subtype, first line treatment Vs second line, or IPI (0–1 Vs 2–3). In a subset analysis of the Z-BEAM group, female gender was associated with worse outcome; 3 years-OS was 69% (95%CI, 48–85%) in female and 93% (95%CI, 79–98%) in male (p=0.042); 3 years-PFS was 54% (95%CI, 34–73%) in female and 81% (95%CI, 65–91%) in male (p=0.032). Those results may be linked to a higher TRM, 23.1% Vs 0% (P=0.002), more respiratory complications 23.1% Vs 4.8 % ( P=0.047) and more admissions to intensive care unit 46,1% Vs 2 % (P< 0.0001) in female than in male group respectively. Conclusions. Z-BEAM is possibly as effective as BEAM alone as a conditioning regimen for ASCT with an increased toxicity. Surprisingly, our series report for the first time an increased toxicity and TRM in female. A longer follow up is needed to asses this results. Disclosures: No relevant conflicts of interest to declare.

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Long-Term Outcome of Patients with Low-Grade Follicular Lymphoma Treated with Yttrium-90 Ibritumomab Tiuxetan: The Mayo Clinic Experience

Blood ◽

10.1182/blood-2019-129391 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 2809-2809 ◽

Cited By ~ 1

Author(s):

Muhamad Alhaj Moustafa ◽

Ricardo Parrondo ◽

Gregory Wiseman ◽

Jennifer Peterson ◽

Thomas E. Witzig ◽

...

Keyword(s):

Median Time ◽

Research Funding ◽

Progression Free Survival ◽

Low Grade ◽

Ibritumomab Tiuxetan ◽

Entire Cohort ◽

Grade 3 ◽

Yttrium 90

Background Follicular lymphoma (FL) is the second most common lymphoma accounting for approximately 15% of all non-Hodgkin's lymphoma (NHL). Yttrium-90 ibritumomab tiuxetan [(90)Y-IT; Zevalin] is a radio-immunoconjugate (RIC) which targets CD20. It is approved in relapsed/refractory low-grade NHL and as consolidation after upfront induction chemoimmunotherapy for FL. This study analyzed patients with previously untreated (UFL) or relapsed/refractory low-grade FL (RFL) treated at our institution with (90)Y-IT. It represents the largest reported cohort for therapeutic use of (90)Y-IT in low-grade FL. Methods Medical records of patients with low-grade FL (WHO grade 1-2) who received treatment with (90)Y-IT at Mayo Clinic Cancer Center between January 2003 and December 2018 were analyzed. Overall response rate (ORR) and complete response rate (CR) were calculated. Progression-free survival (PFS), time to next therapy (TTNT), and overall survival (OS) were analyzed using the Kaplan-Meier method. Results Our cohort consists of 137 patients - 29% (40/137) with UFL and 71% (97/137) with RFL. The median age at diagnosis was 60 years (range, 18-86) with 54% (74/137) males. The median number of previous treatments in RFL patients was 1 (range, 1-5). ECOG performance status at the time of treatment was 0 in 90% and 1 in 10% of patients. 87% (119/137) had stage III/IV disease at the time of (90)Y-IT therapy. The median follow up from the time of (90)Y-IT therapy was 10.2 years (95% CI; 8.8, 11.6); 69% (95/137) of patients are alive. The ORR was 100% in UFL with 93% (37/40) CR while ORR in UFL was 93% (90/97) with 73% (71/97) CR. 45% (48/108) of the CR patients remain in continuous CR (CCR) with a median follow-up of 7 years (95% CI; 5.2, 9.9). CCR was observed in 55% (22/40) of UFL patients compared to 27% (26/97) of RFL patients. 63% (86/137) of patients had relapsed. More relapses occurred in the RFL group (69/97; 71%) compared to the UFL group (17/40; 43%), (p=0.002). In the entire cohort, the median PFS was 2.5 years (95% CI; 2.1, 3.5) and TTNT was 3.6 years (95% CI; 2.5, 4.7). Median PFS was significantly higher in UFL group compared to RFL group- 4.1 years (95% CI; 2.3, NR) vs 2.2 years (95% CI; 1.6, 3.1), respectively (Figure 1-A). Median TTNT was higher in UFL group compared to RFL group- NR (95% CI; 4.1 years, NR) vs 2.4 years (95% CI; 2, 3.6), respectively (Figure 1-B). Median OS (entire cohort) was 18 years (95% CI; 15.8, NR) with no statistically significant difference between UFL group and RFL group; NR (95% CI; NR, NR) vs 18 years (95% CI; 12.3, 20.5), respectively (Figure 1-C). Transformation to high grade lymphoma was seen in 19% (18/97) in RFL group compared to 2.5% (1/40) in UFL group, (p=0.005). Median time to transformation was 4.3 years (range, 1-11). More patients developed therapy-related myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) in the RFL group 14% (14/97) compared to 2.5% (1/40) in the UFL group (p= 0.02). Median time to develop MDS/AML was 3.3 years (range, 0-9.7). Grade ³3 neutropenia was observed in 46% of patients with median time to recovery of 21 days (range, 2-706). Grade ³3 thrombocytopenia was observed in 47% of patients with median time to recovery of 23 days (range, 7-548). Eighteen patients required growth factors support and 14 required transfusions. Non-hematologic AEs included mild to severe fatigue in 35 patients. Conclusion Radio-immunoconjugate therapy with (90)Y-IT is an effective single-agent regimen for low-grade FL. The response and survival data in this large real-world cohort is superior to the pivotal trials of this agent conducted nearly 20 years ago. The data in untreated FL is also of interest and provides the rationale for our current randomized phase 2 trial in untreated FL (https://clinicaltrials.gov/show/NCT02320292). Long-term complete remission (>7 years) was seen in 35% of the study population. Based on these promising results, clinical trials combining RIC with novel agents that could potentiate its effects are warranted. Figure 1 (A) Progression-free survival; comparing time to progression or death after (90)Y-IT treatment between previously untreated patients (UFL) and patients with relapsed/refractory FL (RFL), (B) Time to next therapy; comparing time to starting next line of treatment after (90)Y-IT treatment between UFL and RFL, (C) Overall survival; comparing time to death from all causes after (90)Y-IT treatment between UFL and RFL. Figure 1 Disclosures Tun: DTRM Biopharma: Research Funding; TG Therapeutics: Research Funding; BMS: Research Funding; Curis: Research Funding; Celgene: Research Funding; Mundi-pharma: Research Funding. OffLabel Disclosure: Yttrium-90 ibritumomab tiuxetan [(90)Y-IT; Zevalin] is a radio-immunoconjugate (RIC) which targets CD20. It is approved in relapsed/refractory low-grade NHL and as consolidation after upfront induction chemoimmunotherapy for FL. We are discussing its use as a frontline therapy in low grade FL.

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Early Safety and Efficacy Analysis of a Phase II Study of Sequential R-CHOP and Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) for Elderly High Risk Patients with Untreated DLBCL.

Blood ◽

10.1182/blood.v106.11.926.926 ◽

2005 ◽

Vol 106 (11) ◽

pp. 926-926 ◽

Cited By ~ 12

Author(s):

Paul A. Hamlin ◽

Craig H. Moskowitz ◽

Brett C. Wegner ◽

Carol S. Portlock ◽

David J. Straus ◽

...

Keyword(s):

High Risk ◽

Sudden Death ◽

Elderly Patients ◽

Hematologic Toxicity ◽

Ibritumomab Tiuxetan ◽

Safety And Efficacy ◽

Grade 5 ◽

Grade 3 ◽

Yttrium 90

Abstract Introduction: Elderly patients (pts) with high risk DLBCL represent an increasing demographic, are often underserved in clinical trials, and need improved therapies. By the age-adjusted international prognostic index (aaIPI), pts >60 years (yrs) with high-intermediate (HI) and high risk (H) disease had 5 yr survival (OS) rates of 37%, and 21%, respectively. Rituximab’s addition to CHOP has improved responses and outcomes, but >50% of high risk pts still relapse. We are investigating the safety and efficacy of sequential RCHOP followed by Yttrium-90 ibritumomab tiuxetan (Zevalin ®) radioimmunotherapy (RIT) in an effort to improve these results. An early safety analysis of this sequential program is presented here. Methods: Untreated ASCT-ineligible pts >60 yrs, with aaIPI HI or H risk DLBCL are eligible for study. Induction: pts receive R-CHOP chemotherapy at standard doses q 21 days x 6 cycles with prophylactic pegfilgrastim (or G-CSF) and darbepoetin alfa (Aranesp ®) support. Consolidation: pts with ≥ stable disease at post RCHOP restaging are eligible for 90Y-90 ibritumomab tiuxetan, given 6–9 weeks post RCHOP; For platelet (plt) counts ≥ 150K → 0.4 mCi/kg dose, plt counts of 100–149K → 0.3 mCi/kg. Weekly CBC’s are performed until week 12–13 restaging. Results: 26 pts have been enrolled as of July 12th, 2005. Median age is 75 (range 65–85; male:female 9:17); KPS <80% in 55% (median 70%, range 60–90%); LDH > nl: 89% (range 150–804); Stage III/IV: 11.5% / 88.5 %; Extranodal sites are >1 in 50%; B symptoms in 54%; aaIPI HI (2 factors) = 46%, H (3 factors) = 54%; 18/26 pts have completed RCHOP; 8 pts are off study before RIT for: 4 cardiovascular events (1 CHF,1 Non-Q-wave MI, 1 sudden death, 1 V. Fib arrest), 3 neutropenic sepsis (1=grade 4, 2=grade 5), 1 leptomeningeal progression; 14 pts have received RIT. Median nadir counts during RIT occur at week 6–7: absolute neutrophil count (ANC) = 850 cells/mm3 (0.3–5.4), Hemoglobin (Hgb)= 10.1 gm/dl (6.6–14.6), plt = 28K cells/mm3 (7–103); Grade 3 and 4 ANC = 39%/39%, Hgb 39%/0%, Plt 46%/15%; During RIT, blood and Plt transfusion occurred for 46% and 31%, respectively; colony stimulating factor and erythropoietic support was used in 39% and 31%, respectively. One pt had delayed count recovery post RIT (448 days, transfusion independent from week 12→). Non-hematologic serious adverse events after RIT include: two grade 3 neutropenic infection (1 without fever), 1 grade 5 sudden death at week 7 (autopsy refused). OS and EFS for all pts by intent to treat is 60% and 55%, respectively, with 14 months median followup. Of pts post-RIT >12 weeks (11 pts), none have relapsed with 21 months median follow-up. Conclusions: Treatment of elderly aaIPI HI and H risk DLBCL pts with sequential RCHOP followed by 90Y ibritumomab tiuxetan is feasible and associated with manageable toxicity. Hematologic toxicity with RIT is similar to single agent toxicity, with slightly greater thrombocytopenia that warrants careful follow-up. Toxicity during RCHOP induction is significant in high risk elderly patients and cycle one modification is being implemented. Accrual continues to evaluate the potential long term impact of RIT on EFS and OS.

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Lendalidomide Consolidation After First-Line Chemoimmunotherapy for Patients with Previously Untreated CLL

Blood ◽

10.1182/blood.v116.21.1379.1379 ◽

2010 ◽

Vol 116 (21) ◽

pp. 1379-1379 ◽

Cited By ~ 1

Author(s):

Tait Shanafelt ◽

Han Tun ◽

Curtis Hanson ◽

Clive S. Zent ◽

Jose Leis ◽

...

Keyword(s):

Adverse Events ◽

Research Funding ◽

Residual Disease ◽

Hematologic Toxicity ◽

Consolidation Therapy ◽

Phase Ii Trials ◽

First Line ◽

Grade 3

Abstract Abstract 1379 Background: Although chemoimmunotherapy (CIT) has substantially improved response rates, treatment free survival, and overall survival in patients with chronic lymphocytic leukemia (CLL), only 40–50% of patients achieve a complete remission and the majority have residual disease when evaluated using sensitive assays for minimal residual disease (MRD). While this observation created interest in consolidation therapy, previous alemtuzumab based consolidation trials have demonstrated excess morbidity/mortality. We conducted a lenalidomide based consolidation trial for patients with previously untreated CLL who received 6 cycles of induction with pentostatin, cyclophosphamide and rituximab (PCR). Methods: Eligible patients were previously untreated and had CLL in need of treatment according to the NCI-WG criteria (Blood 111:5446). Treatment schema consisted of 6 cycles of pentostatin (2 mg/m2), cyclophosphamide (600 mg/m2) and rituximab (375 mg/m2) given every 21 days (Blood 109:405). All patients completing 6 cycles of PCR, underwent complete restaging and evaluation for MRD using sensitive flow cytometry (Leukemia 21:956). Following restaging and adequate recovery of blood counts, patients received 6 mos of lenalidomide consolidation by continuous daily administration. The starting lenalidomide dose was 5 mg/day with escalation to 10 mg/day after the first cycle as tolerated. Patients again underwent complete restaging and MRD evaluation after 6 mos of lenalidomide. At the time of this restaging, MRD negative patients entered observation. Those with residual disease continued on lenalidomide and underwent repeat MRD assessment every 3 mos with cessation of lenalidomide when an MRD negative state achieved. Results: 45 patients were enrolled at Mayo Clinic between 3/2008 and 11/2009. 44 patients were eligible for treatment: 71% male, median age 65 (range: 44–78); intermediate Rai risk 61%; high Rai risk 39%. On prognostic testing 32% were CD38+, 52% Zap-70 +, 52% IGHV unmutated, and 16% had high risk FISH (del 17p13; del 11q22). 38 of 44 eligible patients (86%) completed 6 cycles of PCR induction. Adverse events deemed at least possibly related to PCR induction included 19 (43%) patients with grade 3+ hematologic toxicity and 9 (20%) with grade 3+ non-hematologic toxicity. The Overall response rate to induction was 98% with 15 CR/CRi, 3 CCR, 9 nPR, and 16 PR. Four patients with CR were also MRD negative at the completion of induction. Of 38 patients who completed induction, 34 initiated lenalidomide consolidation. Thus, by protocol intent to treat analysis, 34/44 (77%) patients starting CIT with PCR were able to receive consolidation therapy. The remaining patients were unable to initiate consolidation due to: failure to complete induction (6 patients), disease progression (1), adverse event (1) and patient refusal (2). Among the 34 patients who initiated consolidation, the median number of cycles of lenalidomide received was 5.5 (range: 1–19). Adverse events deemed at least possibly related to lenalidomide consolidation included 22 (65%) patients with grade 3+ hematologic toxicity and 4 (12%) with grade 3+ non-hematologic toxicity. Among the 34 patients who received at least 1 cycle of lenalidomide, 4 patients have improved the quality of their response to date with 11 patients still on lenalidomide at the time of this report. After median follow-up of 16 mos, 42/44 patients are alive and median duration of response has not been reached. To date 3/44 (7%) of patients have progressed to require additional treatment. Finally, since eligibility was nearly identical to our historic trial of PCR without lenalidomide consolidation, we compared the 44 patients in the present trial to the 64 patients previously treated on our PCR trial (Blood 109:405). Demographic and prognostic characteristics of the patients in the two studies were similar. With the caveat it represents comparison across phase II trials, the proportion of patients free of retreatment at 12 mos was 97% (95%CI: 91–100) for PCR-L vs. 78% (95%CI: 68–89) for PCR (Figure 1). Conclusion: We report here the first results of lenalidomide based consolidation for CLL patients receiving first-line CIT induction. Although lenalidomide consolidation appears to improve the quality of response and prolong time to retreatment, longer follow-up is necessary to determine the clinical benefit of this strategy. Disclosures: Shanafelt: Celgene: Research Funding; Hospira: Research Funding; Genentech: Research Funding. Off Label Use: Lenalidomide. Kay:Celgene: Research Funding; Hospira: Research Funding; Genentech: Research Funding.

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Consolidation Anti-CD22 Fractionated Radioimmunotherapy with 90Y Epratuzumab Tetraxetan Following R-CHOP In Elderly DLBCL Patients

Blood ◽

10.1182/blood.v116.21.2875.2875 ◽

2010 ◽

Vol 116 (21) ◽

pp. 2875-2875 ◽

Cited By ~ 1

Author(s):

Françoise kraeber-Bodere ◽

Hervé Maisonneuve ◽

Thierry Lamy ◽

Steven Le Gouill ◽

Eric Deconninck ◽

...

Keyword(s):

Phase Ii ◽

International Workshop ◽

Safety Data ◽

Severe Infection ◽

B Cell Lymphoma ◽

Complete Response ◽

Hematologic Toxicity ◽

Consolidation Therapy ◽

Non Hodgkin Lymphoma ◽

Grade 3

Abstract Abstract 2875 Background: Radioimmunotherapy (RIT) is under study as a consolidation treatment after chemotherapy induction in follicular lymphoma patients. This approach also appears interesting in diffuse large B-cell lymphoma (DLBCL) patients >60 years, who are not candidates for bone marrow transplantation. 90Y-epratuzumab tetraxetan (Immunomedics, Inc.) is a radiolabeled humanized anti-CD22 antibody that has been used for a fractionated RIT, showing high rates of durable complete responses with manageable hematologic toxicity in previously-treated indolent and aggressive non-Hodgkin lymphoma (NHL) patients (Morschhauser et al., J Clin Oncol. 2010;28(23);3709-16). A French phase II trial sponsored by the GOELAMS group is ongoing, assessing fractionated RIT using 90Y-epratuzumab tetraxetan as a consolidation therapy after first-line chemotherapy in disseminated DLBCL patients >60 years. The protocol has been designed to include 75 patients; 64 patients have been already enrolled. We report the initial results, in particular safety data, on the first 29 available patients. Design and Method: From October 2008 to November 2009, 29 untreated DLCBL patients >60 years were studied in several French institutions with an initial course of six cycles of R-CHOP14 followed 8 weeks later by two weekly infusions of 90Y-epratuzumab tetraxetan (15 mCi/m2 [555 MBq/m2]) 7 days apart. Hematologic and non-hematologic toxicities were evaluated using NCI-CTC v.3.0. Treatment responses were classified according to the 1999 International Workshop for Response Criteria for NHL. Results: Twenty-six patients underwent the entire course of R-CHOP and 23 received the 2 weekly RIT injections. Following R-CHOP, grade 3–4 neutropenia was observed in 20 patients (68.9%) and grade 3–4 thrombocytopenia in 4 (13.7%). During RIT infusions, 4 patients showed transient change of pulse or blood pressure, with 2 attributed to vasovagal reactions. RIT toxicity included grade 3–4 hematologic toxicity in 18 of 23 patients (78.3%); the most common grade > 3 toxicities were neutropenia (N=18, 78.3%) and thrombocytopenia (N=17, 73.9%). Serious febrile neutropenia was observed in 4 cases (13.8%) after R-CHOP and in 2 patients (8.7%) following RIT. Compared to R-CHOP, RIT non-hematologic toxicity was uncommon; moderate or severe gastrointestinal toxicity was observed in 10 patients (34.5%) after R-CHOP and in 2 (8.7%) following RIT; moderate or severe infection in 9 patients (31.0%) after R-CHOP and in 1 (4.3%) after RIT; and moderate or severe mucositis in 10 (34.4%) patients following R-CHOP, while no patient had mucositis after RIT. Following RIT, red cells and/or platelets transfusions were given to 12 patients (52,2%). Following R-CHOP, 10 of the 25 patients (40.0%) achieved a complete response (CR) or unconfirmed CR (CRu), 13 patients (52.0%) had a partial response (PR) and 2 patients (8.0%) had a stable disease. Six weeks after RIT, 13 patients (56.5%) achieved a CR or CRu, 9 patients (39.1%) had PRs, and 1 patient (4.3%) had progressive disease. Four of 13 patients (30.7%) who achieved less than a CR or CRu with R-CHOP improved their remission status 6 weeks after RIT. Conclusion: These preliminary results indicate the feasibility and safety of fractionated RIT with 90Y-epratuzumab as a consolidation therapy for elderly DLBCL patients. Additional data will be presented at the time of the communication. Disclosures: Off Label Use: monoclonal antibody epratuzumab labeled with yttrium 90 in phase II clinical trial. Wegener:Immunomedics, Inc.: Employment, shareholders. Goldenberg:Immunomedics, Inc.: Employment, shareholders.

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