Mantle Cell Lymphoma Trials

Mantle Cell Phase 3 Trial

Description:
Phase III, multicentre, randomised study of fludarabine/cyclophosphamide combination with or without Rituximab in patients with untreated mantle cell lymphoma

Click to view Mantle Cell Phase III Trial
Trial Summary for Mantle Cell Phase III Trial

Phase:
Phase III

Start:
13/02/2002

End:
01/09/2010

Background:
Mantle Cell Lymphoma (MCL) is an increasingly recognised yet rare sub-type of Non-Hodgkin's Lymphoma (NHL), representing between 5-8% of all cases. Typically it is a disease with a median age of presentation above 60 years and the prognosis is generally poor. Although characterised as a "Low Grade Lymphoma" within the Working Formulation, the five year survival is around 27% which establishes it as one of the worst sub-types of disease.

This study will look at two chemotherapy drugs, Fludarabine and Cyclophosphamide. The combination of these two drugs together seems to work well in patients with mantle cell lymphoma.

In addition to these two drugs, half of the patients will also receive an additional drug called a monoclonal antibody. A monoclonal antibody is a drug that attaches very specifically to the outside of the lymphoma cells and as a consequence the cells can die. The monoclonal antibody treatment, Rituximab, by itself, does work against mantle cell lymphoma but is not as effective as chemotherapy, but the two treatments together may improve this response.

Treatments:
Eligible patients will be registered and randomised to one of two trial arms.

Arm A:
- Fludarabine (40mgs/m2day 1-3)
- Cyclophosphamide (250mgs/m2 day 1-3)
- Cycle repeated every 28 days

Arm B:
- Fludarabine (40mgs/m2day 1-3)
- Cyclophosphamide (250mgs/m2 day 1-3)
- Rituximab (375mgs/m2 day 1 iv infusion)
- Cycle repeated every 28 days.

Objectives:
Primary Objective:
Overall Survival.

Secondary Objectives:
Progression free survival,
toxicity and tumour response.

Methods:
Patients will be given a trial information sheet to read after being approached to the trial.

Those patients who give informed consent will be eligible to take part in the trial.

Enrollment Criteria:
Patients must be over 18 years of age and have a confirmed diagnosis of mantle cell lymphoma.

Patients must have had no previous treatment for their disease, and must have a life expectancy of at least 3 months.

Patients must have normal liver and kidney function, women must agree to take contraceptive precautions during treatment and patients must not have had any previous malignancies in the
previous 5 years.

Health Professionals requiring information on trials and access to our professional section of the website can register here

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Plymouth Hospitals NHS Trust UKCRC Plymouth University Peninsula

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