Rituximab Increases Response to ESHAP in Relapsed, Refractory, and Transformed Aggressive B-Cell Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3067-3067 ◽  
Author(s):  
Lisa Hicks ◽  
Rena Buckstein ◽  
Joy Mangel ◽  
Eugenia Piliotis ◽  
Kevin Imrie ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
B Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Indolent Lymphoma ◽  
Overall Response ◽  
Grade 3 ◽  
Aggressive B Cell Lymphoma

Abstract Background: Patients with relapsed or refractory aggressive B-cell lymphoma, or transformed indolent lymphoma can achieve long-term survival with high dose therapy and autologous stem cell transplant (HDT/ASCT), provided their disease is sensitive to salvage chemotherapy. Unfortunately, approximately 50% of patients are insensitive to standard salvage regimens. Objectives: This trial investigated whether adding Rituximab to ESHAP (etoposide, solumedrol, cytosine arabinoside, cisplatin) induction improved chemosensitivity. The primary outcome was overall response rate (CR + CRu + PR) to R-ESHAP. Secondary outcomes were toxicity, ability to undergo ASCT, progression free survival (PFS) and overall survival (OS). Methods: The protocol was approved by the local ethics review board and all patients provided informed consent. Eligible patients received ESHAP every 28 days with GCSF support until < 15% bone marrow involvement was achieved (2–4 cycles). Rituximab was given weekly x 8 weeks concurrent with the first 2 cycles of ESHAP. GCSF mobilized stems cells were collected on day 10–11 of cycle 1 or 2. Results: The trial was stopped early after the complete response (CR) rate at a planned interim analysis exceeded 40% (a pre-specified criteria for stopping the trial). Final results of 26 patients are presented. Median age was 55.5 years (range 42–64). Twelve patients had relapsed aggressive lymphoma, 2 had refractory disease and 12 had transformed indolent lymphoma. Twenty-two of 26 patients were stage III/IV. The overall response rate to R-ESHAP was 92% (95% CI 82% to 100%). Twelve patients (46%; 95% CI 27% to 65%) had a CR or unconfirmed CR. Grade 3–4 thrombocytopenia, neutropenia, and anemia occurred in 57%, 40%, and 15% of R-ESHAP cycles respectively. Grade 3–4 infections complicated 7% of cycles. Median follow-up was 17 months (range 2.9 to 43.2) from enrollment. Twenty-three of 26 patients (88%) were transplanted. Notable post-transplant toxicity included 5 cases of herpes zoster, 2 cases of bacterial pneumonia, 1 case of pulmonary aspergillosis, and 1 fatal case of pneumocystis carnii pneumonia (PCP). Three patients did not proceed to HDT/ASCT; 2 were refractory to R-ESHAP and 1 died of a myocardial infarction after induction chemotherapy but prior to ASCT. Fifteen of 23 patients who received ASCT remain in remission, 6 have relapsed. Seven patients have died, 4 of progressive disease, 1 of myocardial infarction, 1 of PCP, and 1 of accelerated Parkinson’s Disease. Median PFS and median OS have not yet been reached. Conclusions: In this single-arm, phase II study of relapsed or refractory aggressive B-cell lymphoma and transformed indolent B-cell lymphoma, R-ESHAP induction therapy resulted in a very high ORR (92%) and enabled a large percentage of patients (88%) to proceed to HDT/ASCT. Toxicity of the R-ESHAP regimen was acceptable, and its efficacy compared favorably with other salvage regimens reported in the literature, including R-ICE.

Survival Benefits of Patients with Non-Hodgkin’s Lymphoma Treated with Rituximab Combined with Chemotherapy.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4625-4625
Author(s):  
Zhixiang Shen ◽  
Junmin Li ◽  
Aihua Wang ◽  
Yu Chen
Keyword(s):  
B Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Free Survival ◽  
Overall Response ◽  
Large B Cell

Abstract Purpose: Rituximab combined with chemotherapy has been recommended as first-line or second-line standard regimen in most subtypes of B-cell lymphoma in China by the 2004 National Comprehensive Cancer Network lymphoma therapy guideline. We have conducted a multicenter trial to evaluate the efficacy and safety of rituximab in combination with standard chemotherapy (CHOP) in patients with previously untreated or relapsed indolent and aggressive NHL. Methods: Patients received 4–8 cycles of rituximab plus CHOP every 21 days. For each cycle, rituximab (375mg/m2) was given on day 1 and CHOP started on day 3. CHOP consisted of cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, and vincristine 1.4mg/m2 (maximum 2mg/dose) given intravenously on day 3, and oral prednisone 100mg on days 3–7. Results: A total of 221 patients were enrolled on the trial, 128 males and 93 females with a mean age of 49 years (range 10–83 years). The main lymphoma subtypes were small lymphocytic (15 patients, 7%), follicular (27 patients, 12%), and diffuse large B-cell (160 patients, 72%). In total, 56 patients had indolent NHL and 165 aggressive NHL. The overall response rate for all patients was 86% with 57% complete responses. In patients with indolent NHL the overall and complete response rates were 95% and 55% respectively. After a median 12 months follow up, progression-free survival in patients with indolent NHL was 88%±5% at 1 year and 83%±6% at 2 years. In the 160 patients with diffuse large B-cell lymphoma, the overall response rate was 88% with 61% complete responses, and after a mean follow-up of 6 months, predicted 1-year and 2-year progression-free survival were 88%±5% and 83%±7% respectively. Infusion-related adverse events occurred in 4% of patients, associated with the first infusion of rituximab. Subanalyses according to subtype, stage, IPI and other factors will be presented. Conclusion: Rituximab plus chemotherapy is an effective, well-tolerated treatment that achieves high response rates and long progression-free survival in both indolent and aggressive NHL.

Phase Ib study combining ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8502-8502 ◽  
Author(s):  
Anas Younes ◽  
Ian Flinn ◽  
Jesus G. Berdeja ◽  
Jonathan W. Friedberg ◽  
Sara Alberti ◽  
...  
Keyword(s):  
B Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Cell Lymphoma ◽  
Single Agent ◽  
B Cell Lymphoma ◽  
Primary Objective ◽  
Overall Response ◽  
Large B Cell

8502 Background: Ibrutinib, a first-in-class oral Bruton’s tyrosine kinase inhibitor, has demonstrated single-agent activity in a variety of relapsed or refractory B-cell malignancies with limited toxicity, making it an appropriate drug to combine with standard R-CHOP chemotherapy in patients with previously untreated NHL. Methods: Patients received oral daily dose of ibrutinib (280, 420, or 560 mg) in combination with standard doses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on day 1, and prednisone on days 1 through 5 of each 21-day cycle for up to 6 cycles). The primary objective was to determine the recommended phase 2 dose (RP2D) of ibrutinib in combination with standard R-CHOP (IR-CHOP). The secondary objectives were to assess safety, overall response rate, pharmacokinetics, and pharmacodynamic biomarkers. Results: Seventeen patients (7, 4, and 6 in increasing ibrutinib doses) were enrolled: 59% male, median age 65 (range 46-81) years, diffuse large B-cell lymphoma 47%, mantle cell lymphoma 29% and follicular lymphoma 24%. In the 280 mg cohort, 2 patients had dose-limiting toxicity (DLT): 1 with transient syncope and 1 with periorbital cellulitis; at 560 mg, 1 patient had gastritis (grade 2). The RP2D was established at 560 mg ibrutinib. The most common (≥ 20% of patients) adverse events (AEs) were neutropenia (77%), thrombocytopenia (65%), vomiting (59%), anemia (53%), nausea (47%), fatigue (35%), headache (29%), constipation (24%), diarrhea (24%), and dizziness (24%). To date, 6 patients completed 6 cycles of treatment, and 2 patients discontinued treatment (1 due to noncompliance with the study drug and 1 due to non-DLT AE). At the time of this analysis, of the 10 patients had at least one post baseline tumor, the overall response rate was 100% (7 complete and 3 partial responses). Conclusions: The combination of IR-CHOP has an acceptable safety profile. No new toxicities were noted with adding ibrutinib to R-CHOP. An expansion cohort 560 mg ibrutinib (RP2D) is being opened to further explore the safety and efficacy of IR-CHOP in patients with newly diagnosed diffuse large B-cell lymphomas. Clinical trial information: NCT01569750.

Clinical experience of oxaliplatin-based regimen for patients with relapsed or refractory B-cell lymphoma: A Bangladesh perspective.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19501-e19501
Author(s):  
Ehteshamul Hoque
Keyword(s):  
B Cell ◽  
Patient Population ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Performance Status ◽  
Evaluation Criteria ◽  
B Cell Lymphoma ◽  
Hematological Toxicity ◽  
Overall Response

e19501 Background: We performed a clinical study to evaluate the efficacy and toxicity of R-GemOx in the treatment of patients with relapsed or refractory B-cell lymphoma in Bangladeshi patient population. Methods: A total number of twenty (male 13, female 7, average age 60) patients with recurrent or refractory CD20 positive lymphoma, previously treated with CHOP of any performance status were eligible for inclusion. No primary and new cases were included. Treatment regimen consisting of rituximub 375 mg/m2, Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2on day 1. Cycle was repeated every 3 weekly for six cycles. The patients were enrolled at our institution between December 2009 and December 2011. The primary endpoint was overall response rate and toxicity, assessed by Response Evaluation Criteria, secondary endpoints included both event free survival (EFS), and overall survival (OS). Results: A total of 20 patients were evaluable for efficacy and toxicity. The overall response rate was 75%. The EFS and OS under follow-up. No fatal toxicity was observed. Treatment was generally well tolerated. 13% patients complained about GIT upset (nausea, vomiting). Grade 3/4 neutropenia occurred in 8% of patients. Grade 2 neurotoxicity occurred in 5% of patients. No renal toxicity was observed. No other grade ¾ non hematological toxicity was observed. Conclusions: The combination of R-GemOx was effective in Bangladeshi patient population with Refractory B-cell lymphoma, with a predictable and manageable safety profile similar to that observed in Western patients.

Yttrium-90 (90Y) ibritumomab tiuxetan for treatment of relapsed or refractory non-hodgkin’s lymphoma: The Western Pennsylvania Cancer Institute experience

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 12511-12511
Author(s):  
S. Jasthy ◽  
N. Sudan ◽  
B. Haq ◽  
J. Lister
Keyword(s):  
B Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Response Duration ◽  
Disease Stage ◽  
Ibritumomab Tiuxetan ◽  
Overall Response ◽  
Yttrium 90

12511 Background: Yttrium-90 (90Y) ibritumomab tiuxetan (Zevalin) radioimmunotherapy is an effective agent for treatment of CD20+ B-cell lymphoma (NHL).It is approved for treatment of relapsed or refractory, follicular or transformed B cell lymphoma. An overall response rate ranging from 74% to 82% has been reported. Median response duration of 11.5 to 28.1 months has been reported. Methods: We identified, retrospectively, 37 patients treated at our institution with relapsed or refractory NHL who were treated with 90Y ibritumomab tiuxetan at a dose of 0.3mCi/kg or 0.4mCi/kg. Response rate and survival were assessed. Median age was 60 years (range 28–82 years) of which 65% were male. Follicular lymphoma was present in 57% (n = 21) and diffuse large B-cell lymphoma in 22% (n = 8) of patients. Advanced disease (stage III or IV) was present in 84% (n = 31) of patients. All of the patients had received at least one prior regimen and 68% (n = 25) had received ≥ 3 regimens before 90Y ibritumomab tiuxetan. Results: Overall response rate was 65% (24/37); CR 43% (16/37); PR 19% (7/37); SD 3% (1/37). Duration of response was 13.3 months (range 4 to 48 months) with response duration greater than 12 months in 35% (n = 13) of the patients. Of responders, 67% (16/23) had failed to respond to prior immediate therapy. The only toxic event was pancytopenia, which predictably occurred after treatment. No patients died of toxicity and all toxicity was reversible. Conclusions: 90Y ibritumomab tiuxetan was well tolerated and effective for our patients.We document durable response in our patients with relapsed or refractory NHL and with advanced stage disease. Further study of ibritumomab tiuxetan using different doses and in combination with chemotherapy is warranted. No significant financial relationships to disclose.

scholarly journals High Response Rate and Acceptable Toxicity of R-P-Imvp-16/CBDCA for Relapsed or Refractory Aggressive B-Cell Lymphoma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4418-4418
Author(s):  
Takuro Matsumoto ◽  
Nobuhiko Nakamura ◽  
Yuhei Shibata ◽  
Hiroshi Nakamura ◽  
Ryoko Mabuchi ◽  
...  
Keyword(s):  
Survival Rate ◽  
B Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Salvage Chemotherapy ◽  
Large B Cell Lymphoma ◽  
Grade 3 ◽  
Large B Cell ◽  
Aggressive B Cell Lymphoma

Abstract BACKGROUND: The optimal management of relapsed or refractory aggressive B-cell lymphoma is not standardized. We previously reported the salvage chemotherapy with P-IMVP-16/CBDCA consisting of methylprednisolone (mPSL), carboplatin (CBDCA), etoposide (VP-16), ifosfamide (IFM), and methotrexate (MTX) for patients (pts) with aggressive non-Hodgkin's lymphoma who had previously received CHOP consisting of cyclophosphamide (CPA), doxorubicin (DOX), Vincristine (VCR) and prednisolone (PSL) (Sawada M; Eur J Haematol 2002). The purpose of this study is to determine the efficacy and safety of salvage chemotherapy with rituximab (R) combined with P-IMVP-16/CBDCA (R-P-IMVP-16/CBDCA) for relapsed or refractory aggressive B-cell lymphoma. PATIENTS AND METHODS: We retrospectively analyzed 66 pts with relapsed or refractory aggressive B-cell lymphoma who had received R-P-IMVP-16/CBDCA (R: 375mg/m2 on day1, mPSL: 1000mg/body on days 2-4, IFM: 1000mg/m2 on days 2-6, MTX: 30mg/m2 on day 4 and 11, VP-16: 80mg/m2 on days 2-4, and CBDCA 300mg/m2 on day 2, with granulocyte colony-stimulating factor every 21 days in 5 institutes of Gifu Hematology Study Group between July 2004 and January 2014. The pts who had responded to R-P-IMVP-16/CBDCA underwent autologous transplantation or received 3 additional R-P-IMVP-16/CBDCA cycles. Pts aged 70 or older were given 75% or less of the standard dose. All patients received R-CHOP or R-THP-COP regimen as a first-line chemotherapy. THP (pirarubicin), a derivative of DOX, is an anthracyclin with less cardiotoxicity than DOX. THP-COP has an equivalent efficacy to CHOP (Turumi H; JCRCO 2004). RESULTS: Enrolled 66 pts had a median age of 64.5 years [range 25-83] and were 65% male. The pathology of underlying lymphoma comprised diffuse large-B cell lymphoma (n=51), follicular lymphoma grade 3 (n=11), intravascular large B-cell lymphoma (n=1), primary mediastinal B cell lymphoma (n=1) and mantle cell lymphoma (n=2). The response rate [complete response (CR/CRu) plus partial response (PR)] was 60.6% (40/66), including 28 (42.4%) CR/CRu and 12 (18.2%) PR. Another 5 pts had stable disease and 21 pts progressed. Median overall survival (OS) and progression-free survival (PFS) were 47.1 months and 9.2 months, respectively. The OS rate for the 66 pts was 65.1% at 1 yr and 57.3% at 2 yr. The PFS rate for the 66 pts was 45.6% at 1 yr and 31.2% at 2 yr. The survival rate for the 40 responders was 97.4% at 1 yr and 88.1% at 2 yr, and the survival rate for the 26 non-responders was 15.0% at 1 yr (P<0.001). Common toxicity criteria grade ≥ 3 drug-related adverse events included: neutropenia, anemia, thrombocytopenia and febrile neutropenia. Although the major toxicities were neutropenia and febrile neutropenia, only one DLBCL pt with common variable immunodeficiency died of sepsis related to neutropenia. Non-hematological adverse effects were predominantly mild and tolerable. CONCLUSIONS: The R-P-IMVP-16/CBDCA regimen displayed a significant activity in relapsed or refractory aggressive B-cell lymphoma, with acceptable toxicity and should be considered a candidate for combination chemotherapy. Futher clinical studies should be required. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Interferon Alpha-2B (IFN-a) Is an Effective Agent for the Treatment of Primary Cutaneous T- and B-Cell Lymphoma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2643-2643
Author(s):  
Marina P. Siakantaris ◽  
Marie-Christine Kyrtsonis ◽  
Tatiana Tzenou ◽  
Evangelia M. Dimitriadou ◽  
Maria N. Dimopoulou ◽  
...  
Keyword(s):  
T Cell ◽  
Side Effects ◽  
B Cell ◽  
Median Time ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Low Grade ◽  
Overall Response

Abstract Primary cutaneous lymphoma comprise a wide range of rare diseases of which the commonest T- cell subtypes include mycosis fungoides (MF), Sezary syndrome (SS) and peripheral T-cell lymphoma (PTCL) while follicle center cell lymphoma (FCL), diffuse large B-cell lymphoma (DLBL) and extranodal marginal zone B-cell lymphoma (MZL) represent the B-cell subtypes. The behavior of these diseases is different from nodal NHL and it has been shown that IFN-a can produce long-lasting remissions in early stages MF. On the contrary, there are no reports on the efficacy of IFN- a for primary cutaneous B-cell lymphomas (CBCL). The purpose of this study was to present our experience on IFN -a treatment for patients with both primary T-cell and B-cell cutaneous NHL. Forty-one patients, 25 with primary cutaneous T-cell NHL (CTCL) (16 MF, 4 SS, 5 PTCL) and 16 with CBCL (4 MZL, 3 FCL, 8 DLBL, 1 lymphoblastic NHL) were included in this study. Of the 25 CTCL patients, 20 were males (median age 48y); 16 received IFN-a as first line treatment, 5 after PUVA and 4 after failure of other treatment modalities. Of the 16 CBCL patients, 8 were males (median age 57y); 14 received IFN-a frontline and 2 after treatment failure. Three to 5 MU IFN-a were administered subcutaneously daily with paracetamol prophylactically 1 hour before injection and two hours after. 17 out of 24 CTCL patients responded (overall response rate 71%, 42% CR and 29% PR) (12/16 MF, 1/4 SS and 3/5 PTCL). Median time to response was 4 months (1–17). Median duration of response was 15 months (8–38). 11 patients relapsed, 1 responder rapidly discontinued treatment because of side effects (cataract), the others are still under treatment with IFN-a. Among patients with CBCL 12/14 responded (overall response rate 86%, 64% CR and 22% PR). Median time to response was 2 months (1–4) and median response duration 23 months (13–30); 4 patients relapsed, 1 discontinued treatment because of side effects (depression), another continued with Peg- IFN because of chronic fatigue and the others are still under IFN-a treatment. With respect to histologic subtype, all 4 MZL patients responded; 2/3 FCL and 4/8 DLBL also responded. Flu-like syndrome was observed in the majority of patients at treatment initiation and 60% of patients presented mild leukopenia. In conclusion IFN-a is an effective treatment in primary cutaneous NHL and is usually well tolerated. As already reported response rate is satisfactory in MF. The high response rate observed in CBCL, especially in low-grade subtypes, but also in half of DLBL patients has not been reported previously.

scholarly journals Clinical efficacy and molecular biomarkers in a phase II study of tucidinostat plus R-CHOP in elderly patients with newly diagnosed diffuse large B-cell lymphoma

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Mu-Chen Zhang ◽  
Ying Fang ◽  
Li Wang ◽  
Shu Cheng ◽  
Di Fu ◽  
...  
Keyword(s):  
Elderly Patients ◽  
B Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Molecular Biomarkers ◽  
Newly Diagnosed ◽  
Large B Cell Lymphoma ◽  
Grade 3 ◽  
Large B Cell

Abstract Background Elderly patients with diffuse large B-cell lymphoma (DLBCL) present with poor clinical outcome and intolerance to intensive chemotherapy. Histone deacetylase inhibitors (HDACIs) show anti-lymphoma activities and can be applied to treat DLBCL. This study aimed to evaluate efficacy and safety of oral HDACI tucidinostat (formerly known as chidamide) plus R-CHOP (CR-CHOP) in elderly patients with newly diagnosed DLBCL (International Prognostic Index ≥ 2). Results Among 49 patients, the complete response rate was 86%, with overall response rate achieving 94%. The 2-year progression survival (PFS) and overall survival (OS) rates were 68% (95% CI 52–79) and 83% (95% CI 68–91). Comparing with historical control (NCT01852435), the 2-year PFS and OS rates of double-expressor lymphoma phenotype (DEL) were improved, and negative prognostic effect of histone acetyltransferases CREBBP/EP300 mutations was also mitigated by CR-CHOP. Grade 3–4 neutropenia was reported in 171, grade 3–4 thrombocytopenia in 27, and grade 3 anemia in 11 of 283 cycles. No grade 4 non-hematological adverse event was reported. Conclusion CR-CHOP is effective and safe in elderly patients with newly diagnosed DLBCL. Relevance of DEL phenotype and molecular biomarkers on CR-CHOP response warrants further investigation in DLBCL. Trial registration ClinicalTrial.gov, NCT02753647. Registered on April 28, 2016.

Favorable Results of Rituximab in Combination with CHOP in the Front-Line Treatment of Follicular Lymphoma Grade 3.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2770-2770
Author(s):  
Luis Fayad ◽  
Michael Overman ◽  
Barbara Pro ◽  
Peter McLaughlin ◽  
Felipe Samaniego ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
B Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Bulky Disease ◽  
Large B Cell Lymphoma ◽  
Grade 3 ◽  
Large B Cell

Background: Follicular lymphoma grade 3 has a natural history that is more akin to that of diffuse large B-cell lymphoma. The addition of rituximab to standard CHOP has resulted in improved response and survival in diffuse large B-cell lymphoma. Information about outcomes in follicular lymphoma grade 3 is lacking. Methods: A single institution retrospective review of patients with follicular grade 3 lymphoma evaluated at the UTMDACC from 1999 to 2004. Patients were located from the UTMDACC lymphoma database. All patients were initially treated with R-CHOP. Results: Forty-five patients were identified: 51% male, 47% ≥60 years, and 87% follicular grade 3b. The LDH was elevated in 24%, ECOG performance status was >1 in 2%, and >1 site of extranodal involvement was present in 10%. Stage distribution was 11% stage I, 11% stage II, 42% stage III, and 36% stage IV, bulky disease (>7cm) was present in 11%, and B symptoms occurred in 13%. Beta-2 microglobulin was elevated in 57% with values >3 μg/dL in over 50%. IPI distribution was: 46% IPI Low, 38% LI, 11% IH, and 4% IPI High. Overall response rate was 100% with 96% complete responses. Relapse rate by IPI category was 24% for Low IPI, 18% for IPI LI, and 40% for IPI IH, and 100% for the two patients with High IPI. With median follow-up of 33 months, three year failure-free survival (FFS) is 73% (95% CI: 59 to 87%). One patient died (2%) with an overall survival (OS) at three years of 97% (95% CI: 93 to 100%). Conclusion: The addition of rituximab to CHOP provided a high response rate and excellent early survival in this group of mostly good prognosis patients. Relapses were still seen; longer follow-up is needed.

Phase I/II study of R-ICE (rituximab-ifosfamide-carboplatin-etoposide) with lenalidomide (R2-ICE) in patients with first-relapse/primary refractory diffuse large B-cell lymphoma (DLBCL) in academic and community cancer research united (ACCRU) network.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS8073-TPS8073 ◽  
Author(s):  
Francis Guerra-Bauman ◽  
Betsy LaPlant ◽  
William R. Macon ◽  
Thomas E. Witzig ◽  
Umar Farooq ◽  
...  
Keyword(s):  
Phase I ◽  
B Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Single Agent ◽  
B Cell Lymphoma ◽  
Cell Transplant ◽  
Phase 2 ◽  
Overall Response ◽  
Lymphoma Therapy

TPS8073 Background: Response rates to salvage immunochemotherapy in patients with DLBCL relapsing after or refractory (R/R DLBCL) to front line therapy remain unsatisfactory. Lenalidomide (Len) has significant single agent activity in relapsed/refractory DLBCL. The addition of lenalidomide (Len) days 1-7 to rituximab plus ifosfamide-carboplatin-etoposide (RICE) was shown to be feasible with promising efficacy in phase 1b study (Feldman T, et al. BJH, 2014). We developed phase I/II study to evaluate the safety and efficacy of the addition of Len (extended to 14 day schedule) to RICE (R2-ICE) for R/R-DLBCL patients who are candidates for stem cell transplant. Methods: The phase I portion was designed to determine the maximally tolerated dose Len in combination with RICE using the standard cohort 3+3 design. The escalation dose levels were 15 mg and 20 mg daily x 14 days. Prophylactic aspirin and growth factor support is mandatory. After 2 cycles of therapy response is evaluated with a PET/CT scan; the responding patients are eligible for 1-2 additional cycles of R2ICE as a bridging before HDC/SCT. The estimated overall response rate for two cycles of R-ICE in R/R DLBCL to RCHOP was estimated to be approximate 45%. We hypothesize that the addition of lenalidomide in the relapse setting could increase the overall response rate by approximately 20%. The one-stage design with an interim analysis being utilized in phase 2 requires 45 evaluable patients (one sided alpha = 0.09, power 90%). For Phase I, all types of B-cell lymphomas were eligible. For phase II portion only DLBCL patients are eligible per central pathology review. Other eligibility criteria include: received one line of previous anti-lymphoma therapy, ≥ 2 weeks from completion of prior anti-lymphoma therapy, candidate for HDC and SCT, adequate organ (creatinine clearance ≥ 60ml/min by Cockcroft-, total bilirubin ≤ 2 × ULN) and bone marrow function (ANC) ≥1500/mm3; platelet count ≥75,000/mm3). The use of steroids and/or rituximab up to 1 week prior to registration for management of symptoms is allowed. 9 patients cleared phase 1 without DLT and dose of 20 mg days 1 -14 was recommend for phase 2 part (RP2D) of the study. The phase 2 study passed interim futility analysis and accrual continues. Correlatives include cell of origin by Nanostring, Myc/bcl2 expression and by FISH and minimal residual disease. PET scans are centrally reviewed including metabolic tumor volume. Clinical trial information: NCT02628405 .

Sign in / Sign up

Export Citation Format

Share Document