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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jacqueline Garcia, MD
Study ID
NCT03613532
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Part 1: 6-7 total doses depending on dose level assigned
  • Fludarabine — DRUG
    Given once daily for 4 days
  • Busulfan — DRUG
    Given twice daily for 4 days
  • Venetoclax — DRUG
    Part 2, Part 3, and Part 4: 14 doses for 8-12 cycles depending on dose level assigned
  • Azacitidine — DRUG
    Part 2 and Part 4: 5 doses for 8-12 cycles depending on dose level assigned
  • Decitabine/cedazuridine — DRUG
    Part 3: 3 doses for 8 cycles

Study Details

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.

Key Dates

Start date
Oct 24, 2018
Status verified
May 2026
Primary completion
May 5, 2026
Completion
Mar 5, 2030

Study Design

Enrollment
102 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax
    Part 1 dose escalation * Venetoclax: 6-7 total doses based on level assigned * Busulfan: given 2x daily for 4 days * Fludarabine: given 1x daily for 4 days Part 2 includes post-transplant therapy with azacitidine and venetoclax for 8-12 cycles per dose level. Part 3 includes post-transplant therapy with oral decitabine/cedazuridine and venetoclax for 8 cycles. Part 4 assesses PTCy/Tac/MMF GVHD regimen instead of Tac/Methotrexate -post transplant period includes therapy with azacitidine and venetoclax for 8 cycles.

Primary Outcome Measure

MTD of Venetoclax with Busulfan and Fludarabine [ Time Frame: 37 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MA

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