The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program’s establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.
NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.
This feature highlights an NCCN study funded through the grant mechanism.
Phase II Study of Decitabine and Cedazuridine in Combination With Venetoclax for AML Relapse After Allogeneic Hematopoietic Cell Transplantation
Principal Investigator: Sanjay Mohan, MD
Condition: Acute myeloid leukemia
Institution: Vanderbilt-Ingram Cancer Institute
This phase II trial evaluates how well decitabine + cedazuridine (DEC-C) work in combination with venetoclax in treating patients with relapsed acute myeloid leukemia (AML) after a donor stem cell transplant. DEC-C 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 helps the bone marrow produce normal blood cells 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. Administering DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.
Primary Objective:
• Assess the effect of DEC-C/venetoclax on the investigator-assessed composite complete remission rate (complete remission/complete remission with partial hematologic recovery/complete remission with incomplete hematologic recovery)
Secondary Objectives:
• Assess the rate of partial response and morphologic leukemia- free state following treatment with DEC-C/venetoclax
• Assess relapse-free survival of patients treated with DEC-C/ venetoclax
• Assess overall survival of patients treated with DEC-C/venetoclax
• Assess the safety and tolerability of DEC-C/venetoclax in the post–hematopoietic cell transplant setting
• Assess the rates of measurable residual disease negativity in patients achieving complete remission
Contact: Sanjay Mohan, MD • 800-811-8480 • cip@vumc.org
ClinicalTrials.gov Identifier: NCT05799079
