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

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
University of Rochester
Genentech
Biogen Idec
Information provided by (Responsible Party):
Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00117156
First received: June 30, 2005
Last updated: February 20, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with marginal zone or CD5-, CD10-, CD20+ low-grade B cell lymphomas.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
MALT Lymphoma
Drug: Fludarabine
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Determine the objective response rate following six cycles of fludarabine and rituximab in this population [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety; describe the progression-free survival at one year; examine the association between cytogenetic abnormalities identified by FISH and the objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2003
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fludarabine
    Given intravenously on days 1-5 of every 28-day cycle for 3 cycles.
    Drug: Rituximab
    Given intravenoulsy on day 1 of every 28-day cycle for 3 cycles.
Detailed Description:

The purposes of this study are:

  • To estimate the objective response rate (CR, CRu, PR) to six cycles of concurrent fludarabine and rituximab in patients with disseminated or recurrent CD5-, CD10-, CD20+ low-grade B cell lymphomas.
  • To assess the safety of fludarabine and rituximab in this patient population.
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117156

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14627
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
University of Rochester
Genentech
Biogen Idec
Investigators
Principal Investigator: Jennifer R. Brown, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer R. Brown, MD, PhD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00117156     History of Changes
Other Study ID Numbers: 03-294
Study First Received: June 30, 2005
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Fludarabine
Rituximab
Marginal Zone Lymphoma
MALT lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Fludarabine
Fludarabine monophosphate
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014