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Protocol No. 2012CG016 Principal Investigator Brunstein, Claudio
Phase Phase III
Age Group Adult Scope National
Secondary Protocol No. CTN 1101
Title MT2012-01 : A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow (Haplo) for Patients with Hematologic Malignancies BMT CTN PROTOCOL 1101
Objective The prmary objective is to compare progression-free survival at 2 years post-randomization between patients who receive unrelated double cord blood unit transplantation versus HLA-haploidentical related bone marrow transplantation.
Treatment Patients will be randomized to receive either a donor umbilical cord blood or related HLA-haploidentical bone marrow transplantation.
Description This study is a multi-center trial of reduced intensity conditioning followed by transplantation of two unrelated cord blood units with calcineurin inhibitor and mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) versus HLA-haploidentical related bone marrow with post-transplant cyclophosphamide, calcineurin inhibitor and MMF for GVHD prophylaxis.
Key Eligibility Patient must have 1) acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, or Burkitt's lymphoma in remission; 2) lymphoma, including marginal zone lymphoma, follicular lymphoma, or chemotherapy-sensitive large-cell, Hodgkin or mantle cell lymphoma.
Applicable Disease Sites Hematologic Malignancies
Therapies Involved Blood and Marrow Transplant
Drugs Involved CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
FLUDARABINE (FLUDARA)
Total Body irradiation (TBI)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be between 18 and 70 years of age and with two partially HLA-matched UCB units. Must have adequate organ function. Anyone who has received an autologous hematopoietic stem cell transplant less than 6 months prior to enrollment or prior allogeneic HSCT is not eligible. Women who are pregnant or nursing are not eligible. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org