Mantle Cell Lymphoma Trials

MCL Mini Allo

Description:
Phase II study of low intensity allogeneic transplantation in Mantle Cell Lymphoma

Phase:
Phase II

Start:
-

End:
01/11/2010

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

Transplants are performed in Mantle Cell Lymphoma and cures have been seen, but usually these procedures have been performed after the disease has relapsed. In this study we wish to use a transplant as part of the first treatment course.

In this trial patients will receive a Reduced Intensity Conditioning treatment made up of 4 chemotherapy drugs (Carmustine, Cytarabine, Etoposide and Melphan) together with Campath. This regimen is called BEAM-Campath.

Campath is a monoclonal antibody, which sticks to lymphoma cells and can kill them. In a RIC transplant the Campath also suppresses the patient's immune system, this makes it easier for the donor stem cells to graft in the patient's bone marrow.

Treatments:
Eligible patients will be registered into the trial and all patients will be given the same treatment:

- Reduced Intensity Conditioning regimen (4 chemotherapy drugs plus Campath):

- Carmustine, Cytarabine, Etoposide and Melphalan

- Campath.

- Patients will then receive a stem cell transplant.

Objectives:
Primary
Progression free survival

Secondary
Overall survival, Toxicity by way of adverse event profile

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:
Patient must be at least 18 years of age and considered fit for a transplant by the treating physician

They must have a confirmed diagnosis of Mantle Cell Lymphoma. They must have no other medical conditions that would prevent them having a transplant, and patients must have had a partial or complete response to their initial chemotherapy. A matched donor must be available.

Patients will be excluded from the trial if they have inadequate kidney/liver or heart function, and previous cancer in the last 5 years, or if they are female and pregnant/breastfeeding.

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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