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

NCT03613532 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-20

No results posted yet for this study

Summary

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 102 people will take part in this research study.

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Jacqueline Garcia, MD

    lead OTHER

Principal Investigators

  • Jacqueline S. Garcia, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2026-05-05
Completion
2030-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03613532 on ClinicalTrials.gov