Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
Verified date | July 2016 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 2012 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Rochester Cancer Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Biogen, Genentech, Inc., Massachusetts General Hospital, University of Rochester |
United States,
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 lymph — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | 3.1-Year Progression-Free Survival | 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). | Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years | No |
Secondary | 3.1-Year Overall Survival | 3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry. | Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years | No |
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