Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2015-05-22
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derriford Hospital; University College, London
• Collaborator: Cancer Research UK
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed mantle cell lymphoma (MCL), meeting the following criteria:

• Diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype CD5+, CD23-, sIgM, cyclin D1 nuclear positivity is desirable but not essential

• Central review of histology will be performed on diagnostic material

• Molecular or cytogenetic confirmation of diagnosis is not required

• Previously untreated disease at any stage requiring therapy in the opinion of the treating physician

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months

• Life expectancy not severely limited by other illness

• Creatinine clearance ≥ 30 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during study therapy

• No known serological positivity for HBV, HCV, or HIV

• No concurrent uncontrolled serious medical conditions

• No severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine > 2.5 times upper limit of normal) not related to lymphoma

• No known hypersensitivity to murine proteins

• No prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix

• No history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy