Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.

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Detailed Description

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Objectives:

Primary

\- To estimate the objective response rate.

Secondary

* To assess the safety.
* To describe the progression-free survival at one year.
* To examine the association between clonal cytogenetic abnormalities identified by FISH, and the objective response rate as well as the progression-free survival at one year.

Target enrollment was 30 eligible patients. An 80% objective response rate at 1 month restaging after 6 cycles was considered as evidence of activity in this patient population while 60% was not considered activity. If at least 22 patients achieved objective response the treatment would be considered promising. With 30 eligible patients, the probability of observing this was 0.87 assuming a true rate of 80% and 0.09 assuming a true rate of 60%.

Conditions

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Lymphoma, Non-Hodgkin MALT Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fludarabine and Rituximab

Fludarabine:

25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles

Rituximab:

375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L

Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Interventions

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Fludarabine

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed, newly diagnosed or relapsed MALT, marginal zone lymphoma, or low-grade B cell lymphoproliferative disorder which is CD5-, CD10- and CD20+
* Pathology must be reviewed at Brigham \& Women's Hospital, Massachusetts General Hospital, or the University of Rochester James P. Wilmot Cancer Center prior to enrollment
* Documentation of CD20+ status
* Must not be a candidate for local radiotherapy with curative intent
* If gastric MALT, not a candidate for antibiotic therapy with curative intent
* Patients with leukemic phase marginal zone lymphoma are eligible if their absolute lymphocyte count is \>10,000 / µl
* Prior treatment with rituximab is permitted, if rituximab induced an objective response which persisted for at least 6 months
* Prior radiotherapy is acceptable
* Measurable disease
* ANC: \> 1000/mm3
* Platelets: \> 100,000/mm3
* Hemoglobin: \> 7 gm/dL
* Adequate renal function as indicated by serum creatinine \<= 2 mg/dL.
* Adequate liver function, as indicated by serum total bilirubin \<= 2 mg/dL.
* AST or ALT \<3x Upper Limit of Normal unless related to primary disease.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during study treatment and for six months after completion of study treatment.
* WHO Performance status \</= 2
* Subject has provided written informed consent.

Exclusion Criteria

* Patients with Waldenstrom's Macroglobulinemia or lymphoplasmacytic lymphoma are excluded
* History of HIV
* Active infection
* Known CNS disease
* Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women
* Prior treatment within the last three weeks
* Prior fludarabine
* Positive direct antiglobulin test

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No