IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Alice Mims
Study ID
NCT05401097
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV or SC
  • Biopsy — PROCEDURE
    Undergo biopsy of the bone marrow
  • Enasidenib — DRUG
    Given PO
  • Ivosidenib — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) inhibitors. It works by slowing or stopping the growth of cancer cells. Enasidenib is in a class of medications called an IDH2 inhibitor. It also works by slowing or stopping the growth of cancer cells. 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. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. This study may help researchers determine which treatment order is best for older patients with IDH mutated acute myeloid leukemia: 1) ivosidenib or enasidenib followed by azacitidine plus venetoclax; or 2) azacitidine plus venetoclax followed by ivosidenib or enasidenib.

Key Dates

Start date
Sep 13, 2022
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (IDHi+Aza followed by Ven+aza)
    For IDH1 mutated AML patients randomized to first-line therapy with IDHi+aza, patients will receive Ivosidenib 500mg po orally daily on Days 1-28 of each 28 day cycle. For IDH2 mutated AML patients randomized to first-line therapy with IDHi+aza, patients will receive Enasidenib 100mg po orally daily on Days 1-28 of each 28 day cycle. Azacitidine will be given to both groups intravenously or subcutaneously at 75mg/m2 daily on days 1-7, or 1-5/8-9, or days 1-4/7-9 of each 28-day cycle.Subsequent cycles after CR/CRi/CRh/MLFS achievement may be adjusted in timing and dosing.
  • Experimental: Arm B (Ven+aza followed by IDHi+aza)
    For both IDH1 and IDH2 mutated AML patient randomized to first-line therapy with Ven+aza, patients will receive venetoclax dosing with the ramp-up and dosing per the FDA-label (based off of concurrent drug interactions). Azacitidine will be given intravenously at 75mg/m2 daily on days 1-7, or 1-5/8-9, or days 1-4/7-9 of each 28-day cycle. Subsequent cycles after CR/CRi/CRh/MLFS achievement may be adjusted in timing and dosing.

Primary Outcome Measure

Overall treatment failure [ Time Frame: At 12 months from date of randomization ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UNC Hospitals, University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Study Coordinator
[email protected]
919-966-4432
Joshua Zeidner, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Molly Brandenburg
[email protected]
614-685-9573
Alice S. Mims, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical Center at DallasDallasTexas75235
Donglan Xia, RN, PhD
[email protected]
469-852-0680
Yazan Madanat, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UNC Hospitals, University of North Carolina at Chapel Hill· Chapel Hill, NCOhio State University Comprehensive Cancer Center· Columbus, OHUT Southwestern Medical Center at Dallas· Dallas, TX

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