A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05834244
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given by IV (vein)
  • Venetoclax — DRUG
    Given by PO
  • NK Cells — DRUG
    Given by IV (vein)

Study Details

To learn if adding a healthy person's natural killer (NK) cells to the combination of Azacitidine and Venetoclax can help to control AML. NK cells are cancer- and infection-fighting immune cells.

Key Dates

Start date
Oct 26, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose Escalation to evaluate the combination of azacitidine, venetoclax and allogeneic NK cells in older/unfit participants with AML ineligible for intensive chemotherapy or allogeneic stem-cell transplantation (allo SCT).
  • Experimental: Dose Expansion
    Dose Expansion to evaluate the combination of azacitidine, venetoclax and allogeneic NK cells in older/unfit participants with AML ineligible for intensive chemotherapy or allogeneic stem-cell transplantation (allo SCT).

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Benjamin Tomlinson, MD
[email protected]
Benjamin Tomlinson, MD (PRINCIPAL_INVESTIGATOR)
M.D. Anderson Cancer CenterHoustonTexas77030
Abhishek Maiti, MD
[email protected]
713-792-7305
Abhishek Maiti, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Case Western Reserve University· Cleveland, OHM.D. Anderson Cancer Center· Houston, TX

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