Prolonged Clinical and Molecular Remission in Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma Treated With Rituximab Plus CHOP Chemotherapy: 9-Year Follow-Up

2004 ◽  
Vol 22 (23) ◽  
pp. 4711-4716 ◽  
Author(s):  
Myron S. Czuczman ◽  
Robin Weaver ◽  
Baha Alkuzweny ◽  
Judy Berlfein ◽  
Antonio J. Grillo-López
Keyword(s):  
B Cell ◽  
Hodgkin’S Lymphoma ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Low Grade ◽  
Molecular Remission ◽  
Prior Chemotherapy ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Purpose Long-term follow-up with updated time to disease progression (TTP) and duration of response (DR) data are presented from a multicenter, phase II trial of rituximab/cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combination therapy in 40 patients with CD20+, B-cell, non-Hodgkin's lymphoma (NHL). Revised response rates based on International Workshop Response Criteria are also provided. Patients and Methods Enrollment began in April 1994 and consisted of patients with histologically confirmed, low-grade, B-cell lymphoma who had received no prior chemotherapy or who had no more than four prior standard therapies. Patients received six cycles of CHOP and six infusions of rituximab. Results Eight (21%) of the 38 treated patients were classified as International Working Formulation (IWF) A, 16 (42%) were IWF B, 13 (34%) were IWF C, and one (3%) was IWF D. Nine (24%) of 38 patients had received prior chemotherapy. Nine (24%) of 38 were considered poor risk according to the Follicular Lymphoma International Prognostic Index. Overall response rate was 100%; 87% of patients achieved a complete response or unconfirmed complete response. The median TTP and DR were 82.3 months and 83.5 months, respectively. Seven of eight patients who were bcl-2 positive at baseline converted to negative, and three of the seven patients have sustained the molecular remission. Conclusion Although a cure has not been found yet for follicular NHL, the R-CHOP combination provides a lengthy response duration in patients with relapsed or newly diagnosed indolent NHL.

scholarly journals A phase III, multicentric, open-label, two-arm, parallel group, active-control, randomized, comparative clinical study to evaluate efficacy and safety of RituxiRel™ arm (rituximab) with reference arm (rituximab) in patients with non-Hodgkin's lymphoma

2017 ◽  
Vol 03 (01) ◽  
pp. 017-022 ◽  
Author(s):  
Prasad Apsangikar ◽  
Sunil Chaudhry ◽  
Manoj Naik ◽  
Parvez Kozgi
Keyword(s):  
Partial Response ◽  
B Cell ◽  
Hodgkin’S Lymphoma ◽  
Lymphatic System ◽  
Complete Response ◽  
Safety Analysis ◽  
Hodgkin's Lymphoma ◽  
Efficacy And Safety ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Abstract Introduction: Non-Hodgkin's lymphoma (NHL) is the sixth most common hematological malignancy in adults, with B-cell lymphomas accounting for 85% of all NHLs. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of NHL and follicular lymphoma (FL) is the second most common form of B-cell NHL. Materials and Methods: The primary objective of this study is to assess the efficacy of Rituxirel™ arm with reference arm, whereas the secondary objective is to evaluate safety of Rituxirel™ arm with the reference arm in patients diagnosed with NHL. Results: The first patient was enrolled on April 30, 2012 and the efficacy and safety analysis was performed at 24 weeks. The objective response rate (ORR) was observed to be 87.87% in Rituxirel™ arm. 45.45% patients showed complete response and 42.42% patients showed partial response in Rituxirel™ arm. The ORR was observed to be 86.66% in the reference arm. 33.33% patients showed complete response and 53.33% patients showed partial response in reference arm in the Rituxirel™ arm, the most commonly reported treatment-emergent adverse events (TEAEs) related to blood and lymphatic system disorders were 52.94%, whereas in the reference arm, the reported TEAEs related to blood and lymphatic system disorders were 70%. Conclusion: Based on the results from the efficacy and safety analysis at week 24, Rituxirel™ arm was found to be as effective and safe as the reference arm. Rituxirel™ arm can be a prudent option to the reference arm, in patients undergoing treatment for DLBCL or FL.

Results of Multicentre Phase IV Study of Rituximab in Combination with CHOP Chemotherapy in Patients with Previously Untreated Non-Hodgkin’s Lymphoma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4624-4624
Author(s):  
Ti Shen ◽  
Zhongzhen Guan ◽  
Zhixiang Shen ◽  
Yuankai She ◽  
Jun Zhu
Keyword(s):  
B Cell ◽  
Hodgkin’S Lymphoma ◽  
Response Rate ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Newly Diagnosed ◽  
Chop Chemotherapy ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Phase Iv

Abstract Purpose: Rituximab is a chimeric anti-CD20 monoclonal antibody that was the first antibody approved by the FDA in the United States of America and SDA in China for the treatment of B-cell non-Hodgkin’s Lymphoma (NHL). It has shown significant efficacy and good tolerability in refractory and relapsed NHL. We have conducted a multicenter phase IV trial to evaluate the efficacy and safety of rituximab combined with standard CHOP chemotherapy in patients with newly diagnosed B-NHL. Methods: Patients with newly diagnosed, histologically proven CD20-positive NHL were eligible for the study. All patients received 4–6 infusions of rituximab (375mg/m2 per dose) in combination with CHOP chemotherapy, either concurrently (rituximab administered on the first day of each 21-day CHOP cycle) or sequentially (4–6 once-weekly infusions of rituximab followed by six 21-day cycles of CHOP). Each CHOP cycle consisted of cyclophosphamide 750 mg/m2, doxorubicin 50mg/m2, and vincristine 1.4mg/m2 (maximum 2.0mg/dose) given intravenously on day 1, and prednisone 100mg/day orally on days 1-5. Tumor responses were assessed at the end of treatment. Results: A total of 347 patients were recruited between February 2002 and December 2003. Of these 235 (68%) were male and 94 (27%) aged >60. The main lymphoma subtypes were diffuse large B-cell 196 (56%), follicular 41(12%), small lymphocytic/chronic lymphocytic leukemia 13(4%) and MALT 11(3%). Ann Arbor staging was as follows: stage I, 52 (15%); stage II, 80 (23%); stage III, 90(26%); stage IV, 105(30%); twenty patients (6%) could not be assessed. Of the 347 patients enrolled, 314 were evaluable for response. An objective response was observed in 94% of evaluable patients with a complete response (CR) in 56%, stable disease in 3.8% and progressive disease in 2.5%. The complete response rate was 63% for patients receiving 6 cycles of rituximab and 54% for those receiving four cycles of rituximab. No difference in response rate was observed between the sequential and concurrent groups. The most common adverse events were leucopenia in 122 patients (35%), nausea and vomiting 66 (19%), fever 39 (11%), rash 15 (4%) and asthma 4 (1%). Conclusion: The combination of rituximab and CHOP chemotherapy is an effective and well-tolerated treatment for patients with newly-diagnosed CD20-positive NHL. The safety and efficacy achieved in this study suggests that more than four doses of rituximab may be required for optimal efficacy.

Tumor Targeting, Dosimetry and Clinical Response Data for Lymphorad-131 (LR131; Iodine I-131 Labeled B-Lymphocyte Stimulator) in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 750-750 ◽  
Author(s):  
Andrew Belch ◽  
Alexander McEwan* ◽  
Joanne Hewitt* ◽  
Terence Riauka ◽  
Michael Stabin* ◽  
...  
Keyword(s):  
B Cells ◽  
B Cell ◽  
Pet Imaging ◽  
Hodgkin’S Lymphoma ◽  
B Lymphocyte ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
B Lymphocyte Stimulator

Abstract LR131 is a novel radioconjugate consisting of B Lymphocyte Stimulator (BLyS) protein, a B cell maturation factor of the TNF family that binds selectively to immunoglobulin-positive B cells, labeled with Iodine I 131. BLyS receptors are present on normal B cells and B cell malignancies. Ten subjects with relapsed, refractory follicular non-Hodgkin’s lymphoma (8M/2F, age 33–61) have been entered on study at the Cross Cancer Institute as part of a multicenter phase 1 dose escalation trial. FDG-PET and CT imaging were performed prior to and following LR131 therapy to evaluate tumor response and recurrence. Previous therapies for these patients included single and multiagent chemotherapy, limited field external beam radiation therapy and Rituximab with/without concomitant chemotherapy. Patients had an average of 2.6 previous therapies (range 1–4). Patients received an imaging/dosimetry dose of 5–7 mCi of LR131 followed 1–2 weeks later by the therapeutic dose. CT and PET confirmed specific tumor localization in all patients. Ten of ten patients targeted sites of disease seen on CT and PET with LR131 although one patient with rapidly progressing end stage disease did not uniformly target a very large tumor mass in the abdomen/pelvis. Administered activities for therapy were 0.35 mCi/kg (10 m g/kg BLyS), 0.70 mCi/kg (30 m g/kg BLyS), 1.35 mCi/kg (75 m g/kg BLyS) and 1.70 mCi/kg (75 m g/kg BLyS) for the first four cohorts, respectively. Of 8 evaluable patients through at least 12 weeks of follow-up there were 2 CRu, 2 PR and 1 SD. In the two patients with CRu, follow-up PET scanning was negative for FDG accumulation in all areas of previous activity. One patient had significantly decreased activity on PET (4 weeks) later confirmed as PR by CT. Two patients have been retreated including one CRu (1 year) who showed renewed positive activity on PET imaging (negative CT) which returned to negative following retreatment and 1 PR. There have been no dose limiting toxicities seen to date on initial or retreatment. Time activity curves were generated after drawing ROIs and analyzed with SAAM II. Doses were calculated using MIRDOSE 3.1 (Stabin 1996). Deposited doses to critical organs were 0.48, 0.55, 2.13, 0.49, 0.37 cGy/mCi to the liver, lung, kidney, marrow and total body, respectively, and were significantly lower than those seen with the approved iodine labeled anti-CD20 monoclonal antibody (3.03, 2.92, 7.25, 2.41, 0.89 cGy/mCi for the same organs). LR131 demonstrated rapid clearance from blood and normal organs with retained activity in sites of tumor. Tumor deposited doses ranged from 45 cGy in the patient that did not target to 3600 cGy. CONCLUSION: LR131, at the administered doses studied to date, has been well tolerated with only mild to moderate reversible toxicity. LR131 has demonstrated targeting and clinical efficacy that has correlated with CT and PET imaging

Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (allo-SCT) for Patients with Refractory or Relapsed Non-Hodgkin’s Lymphoma (NHL).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5356-5356
Author(s):  
Hugues de Lavallade ◽  
Reda Bouabdallah ◽  
Catherine Faucher ◽  
Sabine Furst ◽  
Jean El-Cheikh ◽  
...  
Keyword(s):  
T Cell ◽  
B Cell ◽  
Cumulative Incidence ◽  
Hodgkin’S Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Cell Group ◽  
High Grade ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Abstract This study aimed to evaluate the role of RIC allo-SCT for relapsed or refractory non-Hodgkin’s lymphoma (NHL). We report here our experience in 25 consecutive patients transplanted in a single center for high grade (n=17) or follicular NHL (FL; n=8). In the high grade NHL group, median age was 46 (range, 24–63) years, and all 17 patients received 2 or more previous chemotherapy regimens prior to RIC allo-SCT. In addition, 12 patients (71%) had failed autologous SCT and 6 patients (35%) had chemoresistant disease at time of allo-SCT. Among the 8 patients transplanted for a heavily pretreated follicular NHL (FL), median age was 52 (range, 34–59) years and median number of prior lines of therapy was 3 (range, 2–5), with 3 patients (38%) having chemoresistant diseases and 4 patients (50%) relapsing after autologous SCT. Among the 17 patients with aggressive high grade NHL, we compared the outcome of T-cell and B-cell aggressive NHL. With a median follow-up of 15.4 (range, 3.4-65.2) months, the cumulative incidence of non-relapse mortality was 6%, (95%CI, 0.3%-31%) and the Kaplan-Meier estimate of progression-free survival (PFS) was significantly higher in the T-cell as compared to the B-cell group (P= 0.03; 100% vs. 40% at 3 years). In the FL group, the cumulative incidence of non-relapse mortality was 25% (95%CI, 3%–65%). Six patients (75%) showed objective disease response with complete remission (CR) occurring concomitantly to graft-versus-host disease, including one CR after donor lymphocytes infusion. With a median follow-up of 19 (range, 7–85) months, 6 patients from the FL group are still alive of whom 5 in CR. We conclude that a potent graft-vs.-lymphoma (GVL) may be achieved in FL patients, even those with chemoresistant disease or who have relapsed after autologous SCT. In the high grade NHL group, strategies aiming to enhance the GVL effect (Rituximab-based RIC and/or Rituximab maintenance therapy) in the B cell subtype are still needed. However, RIC allo-SCT is a feasible and promising strategy for aggressive NHL, with particularly low toxicity, and T-cell aggressive NHL benefiting most from a potent GVL effect, likely overcoming the poor prognosis usually associated with this phenotype.

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