Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma, Non-HodgkinMALT Lymphoma
- Interventions
- Registration Number
- NCT00117156
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief 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.
- Detailed Description
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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fludarabine and Rituximab 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. Fludarabine and Rituximab Fludarabine 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate Assessed after three- and six-cycles of therapy. Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).
- Secondary Outcome Measures
Name Time Method 3.1-Year Progression-Free Survival Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years 3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999).
3.1-Year Overall Survival Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years 3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry.
Trial Locations
- Locations (4)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States