Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission
M.D. Anderson Cancer Center
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.
Description
PRIMARY OBJECTIVE: I. To assess safety of patients with acute myeloid leukemia (AML) treated with decitabine and cedazuridine (oral decitabine)-based combinations as maintenance therapy after achieving remission. SECONDARY OBJECTIVES: I. To assess relapse-frees survival (RFS) of patients with AML treated with oral decitabine-based combinations as maintenance therapy. II. To assess overall survival (OS) of patients with AML treated with oral decitabine-based combinations as maintenance therapy. III. To assess event-free survival (EFS) of patients with AML treated with oral decitabine-based…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDecitabine and Cedazuridine
Given PO
- DrugEnasidenib
Given PO
- DrugGilteritinib
Given PO
- DrugIvosidenib
Given PO
- DrugVenetoclax
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas