Back to resultsRituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rituximab
fludarabine phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia
Eligibility 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
Sites / Locations
- Arizona Cancer Center
- Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center, UCLA
- Walter Reed Army Medical Center
- Rush-Presbyterian-St. Luke's Medical Center
- Holden Comprehensive Cancer Center
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Tuft-New England Medical Center
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Long Island Jewish Medical Center
- Memorial Sloan-Kettering Cancer Center
- Barrett Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Cross Cancer Institute
- Chedoke-McMaster Hospitals
- Huddinge University Hospital
- Saint Bartholomew's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00020800
First Posted
July 11, 2001
Last Updated
January 7, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00020800
Brief Title
Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenström macroglobulinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos E. Emmanouilides, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tuft-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Chedoke-McMaster Hospitals
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Huddinge University Hospital
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19015393
Citation
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.
Results Reference
result
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Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
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