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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
06/01/2010
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Simon Rule
Recruitment target:
25
EudraCT number:
2007-003081-18
Contact details:
ctc.miniallo@ucl.ac.uk
Lay summary:
MCL MiniAllo
Phase II study of low intensity allogeneic transplantation in Mantle Cell Lymphoma
Description
Design: MCL MiniAllo is a single arm, non−randomised phase II study investigating the use of reduced intensity allogeneic stem cell transplantation for mantle cell lymphoma in first remission.
Treatment: Patients registered onto the trial will receive reduced intensity conditioning using the BEAM-Campath regimen (carmustine, etoposide, cytarabine, melphalan & alemtuzumab).  All patients will then receive a standard allogenic transplant using either peripheral blood stem cells or bone marrow from a matched sibling or unrelated donor.  Patients will be followed up regularly for at least 2 years, and will receive donor lymphocyte infusion if they have disease progression, residual disease or mixed chimerism.  
Key inclusion/exclusion criteria: Patients must aged 18 or over. They must have a confirmed diagnosis of Mantle Cell Lymphoma and be in partial or complete remission following induction treatment.  They must be considered fit for a transplant, with adequate kidney, liver, heart and lung function, and a performance status of 0-2. They must have a matched sibling or unrelated donor available.  Patients are not eligible if they have HIV, a history of hepatitis infection, any concurrent serious medical condition that would preclude an allograft, or if they are pregnant or lactating.   Patients are also ineligible if their lymphoma affected their central nervous system.
Duration of recruitment: 45 months
Aim
The overall aim of this study is to document the toxicity, feasibility and survival following reduced intensity allogeneic transplantation from HLA-compatible sibling or unrelated donors in patients with untreated Mantle Cell Lymphoma. The study will investigate progression free survival, overall survival and rates of transplant-related mortality and graft versus host disease.  
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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