Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00020800
First received: July 11, 2001
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: fludarabine phosphate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 7
Study Start Date: September 2001
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
  • Determine the toxicity of this regimen in these patients.
  • Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.

Patients are followed at least every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of Waldenstrom's macroglobulinemia
  • CD20 positive by bone marrow immunohistochemistry or flow cytometry
  • Presence of monoclonal paraprotein
  • IgM level at least 2 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 25,000/mm^3

Hepatic:

  • Bilirubin less than 2.5 times ULN
  • SGOT less than 2.5 times ULN

Renal:

  • Creatinine less than 2.5 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study
  • No serious comorbid disease
  • No uncontrolled bacterial, fungal, or viral infection
  • No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior rituximab
  • No prior nucleoside analogue therapy

Chemotherapy:

  • At least 30 days since prior chemotherapy

Endocrine therapy:

  • At least 30 days since prior steroid therapy
  • No concurrent corticosteroids

Radiotherapy:

  • At least 30 days since prior radiotherapy

Surgery:

  • Not specified

Other:

  • No more than 2 prior courses of therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020800

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Tuft-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada, L8N 3Z5
Sweden
Huddinge University Hospital
Stockholm, Sweden, SE-141 86
United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00020800     History of Changes
Other Study ID Numbers: CDR0000068714, UCLA-0101063, NCI-G01-1960
Study First Received: July 11, 2001
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Jonsson Comprehensive Cancer Center:
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents

ClinicalTrials.gov processed this record on July 31, 2014