← Back to Search

Anti-metabolites

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

Rochester, NY

Phase 2

Waitlist Available

Led By Jennifer R. Brown, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

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.

See full description

Eligible Conditions

Non-Hodgkin's Lymphoma
MALT Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

3.1-Year Overall Survival

3.1-Year Progression-Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fludarabine and RituximabExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Fludarabine

FDA approved

Do I qualify?Apply below to find out