- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020800
Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Chedoke-McMaster Hospitals
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Stockholm, Sweden, SE-141 86
- Huddinge University Hospital
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England
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London, England, United Kingdom, EC1A 7BE
- Saint Bartholomew's Hospital
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States, 02111
- Tuft-New England Medical Center
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New York
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New Hyde Park, New York, United States, 11040
- Long Island Jewish Medical Center
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45267-0502
- Barrett Cancer Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christos E. Emmanouilides, MD, Jonsson Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Waldenstrom Macroglobulinemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Fludarabine
- Fludarabine phosphate
Other Study ID Numbers
- CDR0000068714
- UCLA-0101063
- NCI-G01-1960
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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