Using decitabine alone or with other drugs to maintain remission in acute myeloid leukemia

Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

This study is testing if the drug decitabine, alone or with other medications, can help keep people with acute myeloid leukemia in remission and improve their chances of staying healthy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: gilteritinib, Chemotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05010772 on ClinicalTrials.gov

What this trial studies

This phase Ib trial evaluates the safety and potential benefits of decitabine, both alone and in combination with venetoclax, gilteritinib, enasidenib, or ivosidenib, for patients with acute myeloid leukemia (AML) who are in remission. The study aims to determine how well these treatments can maintain remission and improve survival outcomes. Patients will be assigned to different treatment arms based on their previous therapy, and the trial will assess various survival metrics and the dynamics of minimal residual disease. The goal is to find effective maintenance therapies that can help control the disease after initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute myeloid leukemia who have achieved their first complete response or complete response with incomplete bone marrow recovery and are not candidates for immediate stem cell transplant.

Not a fit: Patients who have not achieved remission or those who are candidates for immediate allogeneic stem cell transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new maintenance therapy option for patients with acute myeloid leukemia, potentially improving their long-term survival and quality of life.

How similar studies have performed: Other studies have shown promise with similar combinations of decitabine and targeted therapies, indicating a potential for success in this novel approach.

Eligibility criteria

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

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Tapan M Kadia, MD — M.D. Anderson Cancer Center
• Study coordinator: Tapan M. Kadia, MD

Conditions Acute Myeloid Leukemia