A Phase 2 Study of Azacitidine and Venetoclax to Treat Acute Myeloid Leukemia Patients With Measurable Residual Disease Before an Allogeneic Stem Cell Transplant
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out if azacitidine and venetoclax are an effective treatment approach to get rid of or lower measurable residual disease (MRD) in people with acute myeloid leukemia (AML) who have received standard chemotherapy and are planning to have an allogeneic hematopoietic stem cell transplant (HSCT). Allogeneic HSCT, sometimes called a bone marrow transplant, involves receiving healthy blood-forming cells (stem cells) from a donor in order to replace the patient's immune system and lower the chances of the disease returning (relapse).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Adult patient ≥18 years of age at the time of signing the informed consent form (ICF). Legal Authorized Representatives (LAR) are permitted. 2\. Patient is willing and able to adhere to the study visit schedule and other protocol requirements. 3\. Patient has a confirmed diagnosis of de-novo AML (non-APL) as per World Health Organization (2022) guidelines. All (non-APL) subtypes of AML are permitted, irrespective of ELN risk category or mutational status. 4\. Patient has received 1-3 cycles of intensive chemotherapy for remission induction. 5\. Patient is…
Interventions
- DrugAzacitidine (AZC)
75 mg/m2 daily, on days 1-7, given IV or SC
- DrugVenetoclax
Venetoclax 400 mg orally daily on days 1-28
Locations (7)
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York