The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.
Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Infused on Day 0
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
Time frame: 3 years
To evaluate the 6 month transplant related (non-relapse) mortality.
Time frame: 3 years
To evaluate the days to neutrophil engraftment (ANC > 500).
Time frame: 3 years
To evaluate the days of platelet engraftment (platelet count > 20K unsupported).
Time frame: 3 years
To evaluate the risk of acute and chronic graft versus host disease.
Time frame: 3 years
To evaluate percent donor chimerism - contribution of each cord unit.
Time frame: 3 years
To evaluate relapse rate.
To evaluate overall survival.
To evaluate transfusion support needed to cord blood transplant recipients.
Time frame: 3 years
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