Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06514261
Phase
PHASE1
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV or SC
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Buccal Swab — PROCEDURE
    Undergo buccal swab
  • Iadademstat — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This phase I trial tests safety, side effects and best dose of iadademstat with azacitidine and venetoclax for the treatment of patients with acute myeloid leukemia (AML) who have not received treatment (treatment naive). Chemotherapy drugs, such as iadademstat and azacitidine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe and tolerable in treating patients with treatment naive AML.

Key Dates

Start date
Dec 18, 2024
Status verified
May 2026
Primary completion
Sep 16, 2026
Completion
Sep 16, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (iadademstat, venetoclax, azacitidine)
    INDUCTION: Patients receive iadademstat PO QD on days 1-5, 8-12, and may also receive it on days 15-19 of each cycle, venetoclax PO QD on days 1-14 or 1-21 of each cycle, and azacitidine IV over 10-40 minutes or SC on days 1-7 of each cycle or days 1-5 and 8-9 after cycle 1. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo buccal swab collection on study. CONSOLIDATION: Patients receive iadademstat PO QD on days 1-5, 8-12 and may also receive it on days 15-19 of each cycle, venetoclax PO QD on days 1-7 or 1-14 of each cycle, and azacitidine IV over 10-40 minutes or SC on days 1-7 of each cycle or days 1-5 and 8-9 after cycle 1. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.

Primary Outcome Measure

Incidence of dose limiting toxicity (DLT) [ Time Frame: Up to completion of cycle 1 ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhio45219-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Irvine, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Cincinnati Cancer Center-UC Medical Center· Cincinnati, OHUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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