NCT05799079

Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant

Phase 2 Study of Decitabine and Cedazuridine in Combination With Venetoclax for AML Relapse After Allogeneic Hematopoietic Cell Transplantation

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

Summary

This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.

Detailed description

PRIMARY OBJECTIVE: I. To assess the effect of DEC-C/venetoclax on the investigator-assessed composite complete remission (CR) rate (CR/complete remission with partial hematologic recovery \[CRh\]/complete remission with incomplete hematologic recovery \[CRi\]). SECONDARY OBJECTIVES: I. To assess the rate of partial response (PR) and morphologic leukemia free state (MLFS) following treatment with DEC-C/venetoclax. II. To assess the relapse free survival of patients treated with DEC-C/venetoclax. III. To assess overall survival of patients treated with DEC-C/venetoclax. IV. To assess the safety and tolerability of DEC-C/venetoclax in the post-hematopoietic cell transplant (HCT) setting. V. To assess the rates of measurable residual disease negativity in patients achieving a CR. OUTLINE: Patients receive venetoclax orally (PO) daily for 28 days in a 28-day cycle. Patients receive DEC-C PO daily on days 1-5 of a 28-day cycle. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Conditions

• Recurrent Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	Given by mouth
DRUG	Decitabine	Given by mouth
DRUG	Cedazuridine	Given by mouth
PROCEDURE	Bone Marrow Aspiration and Biopsy	Undergo bone marrow biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2023-04-13
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2023-04-05
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study