Venetoclax in Pre- and Post-Transplant Therapy

A Phase 1 Study of Adding Venetoclax to a Reduced Intensity Conditioning Regimen and to Maintenance in Combination With a Hypomethylating Agent After Allogeneic Hematopoietic Cell Transplantation for Patients With High Risk AML, MDS, and MDS/MPN Overlap Syndromes

What's the purpose of the trial?

This clinical trial involves individuals who have been diagnosed with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or MDS/myeloproliferative neoplasm-unclassifiable (MDS/MPN-unclassifiable) and are planning to have an allogeneic hematopoietic stem cell transplant ("bone marrow transplant"). The goal of this research study is to (1) test the safety of adding the study drug, Venetoclax, to a standard of care conditioning regimen for bone marrow transplantation as a possible means of eliminating residual (left-over) disease prior to transplant, (2) to test the safety of combination Venetoclax and azacitidine as "maintenance therapy" after transplant to possibly prevent disease recurrence and (3) to test the safety of combination Venetoclax and oral decitabine/cedazuridine as "maintenance therapy" after transplant to possibly prevent disease recurrence. * The name of the study drug involved in this study is Venetoclax. * It is expected that about 68 people will take part in this research study.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
100
Last Updated
5 months ago
Am I Eligible

Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Azacitidine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Busulfan is a chemotherapy cancer medication that interferes with the growth and spread of cancer cells in the body, and may be used in the treatment of many different cancers.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Inqovi is an oral chemotherapy medication. It combines two different drugs, decitabine, which is a hypomethylating chemotherapy agent, and cedazuridine, which is a CDA inhibitor that helps decitabine to work effectively in the body.
  • Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death. 

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Part 1

Accepting patients

Part 2

Accepting patients

Part 3

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