Cladribine in Patients With Mantle Cell Lymphoma
- Registration Number
- NCT00002879
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effects of cladribine in previously treated or untreated patients with mantle cell lymphoma.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of cladribine (2-chlorodeoxyadenosine; 2-CdA) as treatment for mantle cell lymphoma (MCL) either as initial therapy or for relapsed/refractory disease. II. Determine by flow cytometry immunophenotyping of blood lymphocytes the number of patients with peripheral blood involvement at the time of diagnosis and compare the presence or absence of peripheral blood involvement with response data. III. Detect rearrangements involving the bcl-1 gene and immunoglobulin heavy chain locus by molecular techniques (e.g., polymerase chain reaction, Southern blotting, or in situ hybridization), and compare these results with immunohistochemical demonstration of bcl-1 protein expression. VI. Determine the proliferative rate of MCL by immunohistochemistry and DNA content flow cytometry. V. Summarize the toxic effects associated with this treatment.
OUTLINE: Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in complete remission or with stable disease discontinue treatment and are followed; those with disease progression at any time are removed from study. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cladribine cladribine Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in complete remission or with stable disease discontinue treatment and are followed; those with disease progression at any time are removed from study. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years.
- Primary Outcome Measures
Name Time Method Overall response Up to 4 years Overall survival Up to 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States