Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
1 other identifier
interventional
26
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2003
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
October 6, 2014
CompletedAugust 1, 2016
July 1, 2016
4.8 years
June 30, 2005
September 26, 2014
July 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
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).
Assessed after three- and six-cycles of therapy.
Secondary Outcomes (2)
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 Overall Survival
Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years
Study Arms (1)
Fludarabine and Rituximab
EXPERIMENTALFludarabine: 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Massachusetts General Hospitalcollaborator
- University of Rochestercollaborator
- Genentech, Inc.collaborator
- Biogencollaborator
Study Sites (4)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Rochester Cancer Center
Rochester, New York, 14627, United States
Related Publications (1)
Brown JR, Friedberg JW, Feng Y, Scofield S, Phillips K, Dal Cin P, Joyce R, Takvorian RW, Fisher DC, Fisher RI, Liesveld J, Marquis D, Neuberg D, Freedman AS. A phase 2 study of concurrent fludarabine and rituximab for the treatment of marginal zone lymphomas. Br J Haematol. 2009 Jun;145(6):741-8. doi: 10.1111/j.1365-2141.2009.07677.x. Epub 2009 Mar 30.
PMID: 19344412RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer R. Brown, MD, PhD
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer R. Brown, MD, PhD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 4, 2005
Study Start
December 1, 2003
Primary Completion
October 1, 2008
Study Completion
January 1, 2012
Last Updated
August 1, 2016
Results First Posted
October 6, 2014
Record last verified: 2016-07