NCT03393611

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myeloid, Acute
• Leukemia, Relapsed Adult Acute Myeloid
• Myelodysplastic Syndromes, Previously Treated

Interventions

Type	Name	Description
DRUG	CPX-351	Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17
DRUG	Fludarabine	Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3)
DRUG	Melphalan	Melphalan 140 mg/m2 (Day -2)
DRUG	Rabbit Anti-Human T-Lymphocyte Globulin	Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days)
BIOLOGICAL	Haplo-Cord Stem Cell Transplantation	Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit.

Timeline

• Start date: 2012-11-30
• Primary completion: 2021-08-30
• Completion: 2021-11-18
• First posted: 2018-01-08
• Last updated: 2022-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study