Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma

Sponsor
International Extranodal Lymphoma Study Group (IELSG)
Study ID
NCT02853370
Phase
PHASE2
Status
Completed

Conditions

  • Marginal Zone B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
May 2022
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: At the end of treatment (After 24 weeks of treatment) ]

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