Actively Recruiting
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
125
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with acute myeloid leukemia who have achieved their first complete response or complete response with incomplete bone marrow recovery and are not immediate candidates for stem cell transplant
- Patients who received intensive remission induction therapy and at least one consolidation cycle, within 2 months from last consolidation therapy (Cohort 1)
- Patients who received at least two cycles of lower intensity therapy to achieve remission (Cohort 2)
- Patients with measurable residual disease may enroll in respective cohorts without time limit from consolidation
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Serum total bilirubin less than or equal to 1.5 times the upper limit of normal
- Serum creatinine less than or equal to 2.5 times the upper limit of normal
- Absolute neutrophil count greater than 0.5 x k/uL
- Platelet count of 50 x k/uL or higher
- Female participants of childbearing potential must have a negative pregnancy test within 10 to 14 days before enrolling and agree to abstinence or use of two effective contraceptive methods during treatment and for 30 days after
- Male participants with female partners of childbearing potential must agree to abstinence or use of two effective contraceptive methods during treatment and for 30 days after
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) or AML M3 subtype
- Diagnosis of AML with t(15;17) translocation or APL variant; patients with t(9;22) translocation unless unable or unwilling to receive tyrosine kinase inhibitor therapy
- Uncontrolled illness such as active uncontrolled infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
- Active central nervous system disease
- Known hypersensitivity to any study treatment components
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- History of extramedullary AML except for controlled CNS involvement
- Current participation in another clinical trial or desire to join another trial requiring removal from this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tapan M. Kadia, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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