Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN | Aplastic Anemia & MDS International Foundation
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN

Clinical Trial: NCT03613532

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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 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.

  • The name of the study drug involved in this study is Venetoclax.
  • It is expected that about 38 people will take part in this research study.
Status: 
Recruiting
Study Date: 
Fri, 08/03/2018 to Thu, 10/01/2020
Bone Marrow Disease(s): 
  • acute myeloid leukemia (AML)
  • chronic myelomonocytic leukaemia (CMML)
  • myelodysplastic syndromes (MDS)
  • myeloproliferative neoplasms (MPN)
Intervention: 
This trial can be divided into three periods: 1) Screening, 2) Treatment including venetoclax + FluBu2 and transplantation; and 3) Post-Transplant follow up. Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Venetoclax: 6-7 total doses depending on dose level assigned FLuBu2 Busulfan: given twice daily for 4 days Fludarabine : given once daily for 4 days Interventions: Drug: Venetoclax Drug: Fludarabine Drug: Busulfan