NCT00002879

Cladribine in Patients With Mantle Cell Lymphoma

A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH MANTLE CELL LYMPHOMA (MCL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	cladribine

Timeline

• Start date: 1996-11-01
• Primary completion: 2005-04-01
• Completion: 2008-12-01
• First posted: 2004-08-24
• Last updated: 2016-12-07

Locations

21 sites across 2 countries: United States, Canada