This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17
Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3)
Melphalan 140 mg/m2 (Day -2)
Weill Cornell Medical College
New York, New York, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 1 year
Neutrophil Engraftment
Evaluate the time to neutrophil engraftment, defined as the first day in which absolute neutrophil count (ANC) \>500/mm3 for three consecutive days
Time frame: 100 days
Overall Survival at Day 100, 6 months, and 1 year
Evaluate survival of subjects alive, with or without presence of disease, at the designated time points
Time frame: Day 100, 6 months, and 1 year post-transplant
Disease-Free Survival at Day 100, 6 months, and 1 year
Evaluate survival of subjects alive without disease at the designated time points
Time frame: Day 100, 6 months, and 1 year post-transplant
Non-Relapse Mortality
Death that cannot be explained by persistence, relapse, or progression of underlying disease
Time frame: Day 100
Relapse Rate
Time to first relapse or progression of underlying disease after initiation of protocol therapy
Time frame: Day 100, 6 months, 1 year
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Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days)
Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit.