Recruiting
Phase 1

Decitabine, Venetoclax, Gilteritinib, Enasidenib, Ivosidenib

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05010772

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decitabine and Cedazuridine

Enasidenib

Gilteritinib

Ivosidenib

Venetoclax

Study Details

Brief summary:

This phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, 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 may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Gilteritinib, enasidenib, and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine alone or together with venetoclax, gilteritinib, enasidenib, or ivosidenib may help to control the disease.

Conditions

Acute Myeloid Leukemia

Study ID

NCT05010772

Start date

Oct 25, 2021

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients aged >= 18 years AML who have achieved their FIRST complete response (CR) or complete response with incomplete bone marrow recovery (CRi) and are not immediately candidates for allogeneic stem cell transplant
  • Patients who have received intensive therapy (defined as receiving standard or higher dose cytarabine-based therapy) to achieve remission (CR/CRi) should have received remission induction therapy and at least 1 consolidation cycle. These patients are eligible as long as they are not greater than 2 months from their last consolidation therapy and will be designated as COHORT 1 (intensive induction cohort)
  • Patients who have received lower intensity therapy (defined as receiving low-dose cytarabine \[LDAC\] or hypomethylating agent \[HMA\]-based therapy) to achieve remission should have received at least 2 cycles of lower intensity therapy between the time they have achieved CR/CRi and enrollment on this protocol. They will be designated as COHORT 2 (lower intensity induction cohort)
  • For either subgroup (lower or higher intensity), patients who have measurable residual disease may be enrolled on their respective cohort at any time without maximum 'time from consolidation' requirement
  • Eastern Cooperative Oncology Group (ECOG) performance status of < or = 3
  • Serum total bilirubin < or = to 1.5 x the upper limit of normal (ULN)
  • Serum creatinine < or = to 2.5 x ULN
  • Absolute neutrophil count (ANC) > 0.5 x k/uL
  • Platelet count > or = 50 x k/uL
  • For females of childbearing age, they may participate if they:

  • Have a negative serum or urine pregnancy test within 10 to 14 days of enrolling
  • Agree to either abstinence or 2 effective contraceptive methods (such as barrier methods or hormonal contraception) throughout the treatment period and up to 30 days after discontinuing treatment
  • For male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment
  • Ability to understand and sign informed consent

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French-American-British (FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics studies
  • Diagnosis of AML associated t(15;17) or APL variant. Patients with t(9;22) are also ineligible unless they are unable or unwilling to receive therapy with a tyrosine kinase inhibitor
  • Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with active CNS (central nervous system) disease
  • Patients with documented hypersensitivity to any components of the study program
  • Females who are pregnant or lactating or intending to become pregnant during the study
  • Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment
  • Patient should be removed from current trial if they wish to participate and get treatment on another trial

Study Design

Enrollment

125 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (decitabine and cedazuridine)

Patients receive decitabine and cedazuridine PO QD on days 1-3. Treatments repeat every 28 days for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

experimental: Arm B (decitabine and cedazuridine, venetoclax)

Patients receive decitabine and cedazuridine PO QD on days 1-3 and venetoclax PO QD on days 1-5. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

experimental: Arm C (decitabine and cedazuridine, gilteritinib)

Patients receive decitabine and cedazuridine PO QD on days 1-3 and gilteritinib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

experimental: Arm D (decitabine and cedazuridine, enasidenib)

Patients receive decitabine and cedazuridine PO QD on days 1-3 and enasidenib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

experimental: Arm E (decitabine and cedazuridine, ivosidenib)

Patients receive decitabine and cedazuridine PO QD on days 1-3 and ivosidenib PO QD on days 1-28. Treatments repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Interventions

Decitabine and Cedazuridine

Given PO

Enasidenib

Given PO

Gilteritinib

Given PO

Ivosidenib

Given PO

Venetoclax

Given PO

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Tapan M. Kadia, MD

713-792-7305tkadia@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Tapan M. Kadia

713-792-7305tkadia@mdanderson.org

Principal Investigator:

Tapan M. Kadia

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-16.