NCT04526288

CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease

A Randomized Trial for Patients With High-Grade Myeloid Neoplasms With Measurable Residual Disease (MRD): CPX-351 vs. Immediate Allogeneic Hematopoietic Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effect of CPX-351 followed by donor stem cell transplantation versus immediate donor stem cell transplantation in treating patients with high-grade myeloid cancers with measurable residual disease. Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before donor stem cell transplantation may help kill cancer cells in the body and make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 arms. Arm A: Patients undergo alloHCT. Arm B: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT. After completion of study enrollment, patients will be followed for up to 2 years.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome With Excess Blasts-2
• Myeloid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo alloHCT
DRUG	Liposome-encapsulated Daunorubicin-Cytarabine	Given IV

Timeline

• Start date: 2021-08-09
• Primary completion: 2023-08-27
• Completion: 2023-08-27
• First posted: 2020-08-25
• Last updated: 2024-05-23
• Results posted: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study