Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission
Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Treatments repeat every 28 days for up to 4 weeks in the absence of disease progression or unacceptable toxicity."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the side effects and possible benefits of decitabine alone or with venetoclax, gilteritinib, enasidenib, or ivosidenib. It is for adults with acute myeloid leukemia (AML), a blood cancer, in their first remission, meaning the cancer is under control. The goal is to help keep the disease under control.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with AML in first remission, even if blood cell counts have not fully recovered. A donor stem cell transplant must not be an immediate option.
- After intensive treatment: must have had treatment to reach remission and at least 1 follow-up treatment cycle. The last cycle must have ended no more than 2 months ago.
- After lower-intensity treatment: must have had at least 2 more treatment cycles after reaching remission.
- If tests still find small amounts of leukemia, patients in either treatment group may join without the maximum time limit after follow-up treatment.
- Must meet the study’s physical activity limit (ECOG score of 3 or less) and be able to understand and sign the consent form.
- Blood tests must meet liver and kidney limits: bilirubin no more than 1.5 times normal and creatinine no more than 2.5 times normal.
- Must have enough blood cells: neutrophils, which fight infection, above 500 per microliter; platelets, which help stop bleeding, at least 50,000 per microliter.
- Women who can become pregnant need a negative pregnancy test within 10–14 days before joining. They and men with partners who can become pregnant must avoid sex or use 2 effective birth control methods during treatment and for 30 days after.
Who can't join
- A type of leukemia called acute promyelocytic leukemia (APL), including AML-M3, APL variants, or AML with the t(15;17) chromosome change.
- AML with the t(9;22) chromosome change, unless unable or unwilling to take a targeted drug called a tyrosine kinase inhibitor.
- An uncontrolled illness, such as an infection or certain heart problems, or mental health or social issues that would prevent following study rules.
- Active leukemia in the central nervous system—the brain and spinal cord.
- A known allergy to any part of the study treatment.
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Past AML outside the bone marrow, except disease in the brain or spinal cord that is now controlled.
- Patients must leave this study if they choose to receive treatment in another trial.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Tapan M. Kadia · Study contact · 713-792-7305 · tkadia@mdanderson.orgTapan M. Kadia · Principal investigatorMore trials in Houston