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Subjects will receive CPX-351 salvage chemotherapy on Day -21, -19, and -17 as a bridge to allogeneic stem cell transplantation using a Fludarabine/Melphalan/rATG conditioning regimen and a haplo-cord graft.

Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17

CPX-351

Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3)

Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days)

Rabbit Anti-Human T-Lymphocyte Globulin

Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit.

Haplo-Cord Stem Cell Transplantation

Sebastian Mayer, MD

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.

CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome

A Pilot Study of a Novel Sequential Treatment Utilizing CPX-351 as Salvage Chemotherapy Followed by Allogeneic Stem-Cell Transplantation (SCT) Utilizing a Haplo-cord Graft for Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

Evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Evaluate the time to neutrophil engraftment, defined as the first day in which absolute neutrophil count (ANC) \>500/mm3 for three consecutive days

Evaluate survival of subjects alive, with or without presence of disease, at the designated time points

Evaluate survival of subjects alive without disease at the designated time points

Death that cannot be explained by persistence, relapse, or progression of underlying disease

Time to first relapse or progression of underlying disease after initiation of protocol therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome	NCT03393611	Myelodysplastic... Leukemia, Myelo... Leukemia, Relap... Myelodysplastic...	CPX-351 Fludarabine Melphalan Rabbit Anti-Hum... Haplo-Cord Stem...	18 Years - 89 Years	Weill Medical College of Cornell University
CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome	NCT03393611	Myelodysplastic... Leukemia, Myelo... Leukemia, Relap... Myelodysplastic...	CPX-351 Fludarabine Melphalan Rabbit Anti-Hum... Haplo-Cord Stem...	18 Years - 89 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for leukemia, relapsed adult acute myeloid