Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma
|ClinicalTrials.gov Identifier: NCT02853370|
Recruitment Status : Active, not recruiting
First Posted : August 2, 2016
Last Update Posted : May 14, 2020
Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the disease pursues an aggressive course and most patients die of lymphoma progression within 3-4 years.
Retrospective studies have indicated that purine analogous achieved very high response rates in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in combination with chemotherapy has been reported to be very effective in producing a rapid clearance of neoplastic cells.
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone B-cell Lymphoma||Drug: Bendamustine and Rituximab||Phase 2|
Prospective, multicenter, open-label, phase II study, designed to determine efficacy and safety of a Chemo-immunotherapy with the combination of bendamustine + rituximab in patients with splenic marginal zone lymphoma.
Study Population: previously untreated (except for splenectomy and/or antiviral therapy for Hepatitis C Virus (HCV) infection) and symptomatic Splenic Marginal Zone patients.
Objectives: evaluation of the efficacy and the safety of R-Bendamustine in symptomatic Splenic Marginal Zone Lymphoma patients.
Primary Objective: efficacy of R-Bendamustine measured by Complete Response rate. Complete response rate defined as regression to normal size on CT of organomegaly (spleen, liver, lymph nodes); normalization of the blood counts and no evidence of circulating clonal cells, and no evidence or minor (≤ 5%) Bone Marrow (BM) infiltration detected by immunohistochemistry (IHC).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma. The International Extranodal Lymphoma Study Group (IELSG) 36 Phase II Prospective Study|
|Actual Study Start Date :||July 2012|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Bendamustine and Rituximab
Induction Phase (Cycle 1 to Cycle 3 ):
Bendamustine 90 mg/sqm i.v. d1 & d2* Rituximab 375 mg/m2 i.v. d1**
Extended Phase (Cycle 4 to Cycle 6):
Bendamustine 90 mg/sqm i.v. d1 & d2* Rituximab 375 mg/m2 i.v. d1
From Cycle 4 to Cycle 6, every 4 weeks, depending on the response after the first 3 Cycles
*Or days 2-3 according to institutional/patient/physician preference
**Administration of Rituximab during cycle 1 and cycle 2 can be postponed to day 8 or 14 in case of risk of tumor lysis syndrome (TLS)
Drug: Bendamustine and Rituximab
- CT-scan of organomegaly (spleen-liver-lymph nodes) [ Time Frame: up to 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853370
|Study Chair:||Emilio Iannitto, MD||Presidio ospedaliero G. Moscati; UOC di Ematologia - Taranto|