Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Part of paid clinical trials in Miami, Florida.

Sponsor
Antonio M Jimenez Jimenez
Study ID
NCT06158100
Phase
PHASE1
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax will be given orally (PO) at the assigned doses of 50 or 100 mg once daily for 7, 14 or 21 days starting at day 1 of each 28-day cycle, for up to 12 cycles.
  • Azacitidine — DRUG
    Azacitidine will be administered at a dose of 20mg/m\^2 once daily subcutaneously (SC) or intravenously (IV) for five days (Days 1-5) of each 28-day cycle.
  • Donor Lymphocyte Infusion — BIOLOGICAL
    Donor lymphocyte infusions (DLI) may be administered at the discretion of the treating physician, if certain criteria are met. Participants may receive up to three (3) infusions of donor lymphocytes (a type of white blood cell) at the following dose levels and study timepoints: * DLI 1: 1x10\^6 cluster of differentiation 3+ (CD3+) cells/kg, after cycle 3 * DLI 2: 5x10\^6 CD3+ cells/kg, after cycle 5, if there is persistent MRD * DLI 3: 1x10\^7 CD3+ cells/kg, after cycle 7, if there is persistent MRD.

Study Details

The purpose of this study is to see the effects of an investigational combination treatment of venetoclax, azacitidine, and donor lymphocyte infusion (DLI) in patients with high-risk AML receiving allogeneic hematopoietic cell transplantation, and to assess if the combination treatment is well tolerated and prevents disease relapse after transplant.

Key Dates

Start date
Dec 4, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VEN/AZA Dose Escalation/De-Escalation Cohort
    Participants in this group will begin Venetoclax and Azacitidine (VEN/AZA) combination therapy between day +42 and day +100 following hematopoietic cell transplant (HCT) infusion. VEN/AZA combination therapy will be administered for up to six (6) cycles, followed by up to six (6) additional cycles of Venetoclax monotherapy in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days. Participants may also receive donor lymphocyte infusions (DLI) at the discretion of the treating physician, if certain criteria are met. Participants will receive up to one year (12 cycles) of study therapy, followed by up to one year of follow-up. Total participation duration is up to two years.
  • Experimental: VEN/AZA Expansion Cohort
    Participants in this group will receive VEN/AZA therapy at the most appropriate dose determined in Part 1. Participants may also receive donor lymphocyte infusions (DLI) at the discretion of the treating physician, if certain criteria are met. Participants will receive up to one year (12 cycles) of study therapy, followed by up to one year of follow-up. Total participation duration is up to two years.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 13 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami· Miami, FL

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