NCT03613532View on ClinicalTrials.gov

Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

October 24, 2018

Primary Completion Date

December 1, 2025

Study Completion Date

February 1, 2026

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)Chronic Myelomonocytic Leukemia (CMML)MDS/Myeloproliferative Neoplasm-unclassifiable (MDS/MPN-unclassifiable)Hematopoietic Stem Cell Transplant
Interventions
DRUG

Venetoclax

Part 1: 6-7 total doses depending on dose level assigned

DRUG

Fludarabine

Given once daily for 4 days

DRUG

Busulfan

Given twice daily for 4 days

DRUG

Venetoclax

Part 2, Part 3, and Part 4: 14 doses for 8-12 cycles depending on dose level assigned

DRUG

Azacitidine

Part 2 and Part 4: 5 doses for 8-12 cycles depending on dose level assigned

DRUG

Decitabine/cedazuridine

Part 3: 3 doses for 8 cycles

Trial Locations (1)

02215

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Jacqueline Garcia, MD

OTHER