Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
NCT ID: NCT00020800
Last Updated: 2013-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
7 participants
INTERVENTIONAL
2001-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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rituximab
fludarabine phosphate
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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Christos E. Emmanouilides, MD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada
Huddinge University Hospital
Stockholm, , Sweden
Saint Bartholomew's Hospital
London, England, United Kingdom
Countries
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References
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Treon SP, Branagan AR, Ioakimidis L, Soumerai JD, Patterson CJ, Turnbull B, Wasi P, Emmanouilides C, Frankel SR, Lister A, Morel P, Matous J, Gregory SA, Kimby E. Long-term outcomes to fludarabine and rituximab in Waldenstrom macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17.
Other Identifiers
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UCLA-0101063
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1960
Identifier Type: -
Identifier Source: secondary_id
CDR0000068714
Identifier Type: -
Identifier Source: org_study_id
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