Clinical trial · Interventional
Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
OAG and Decitabine for Newly Diagnosed Acute Myeloid Leukemia Patients Greater Than or Equal to 65 Years of Age
NCT02029417CI-TRIAL-00022051terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Major revisions needed in study
Summary
Brief summary (as posted)
This phase II trial studies the side effects and how well omacetaxine mepesuccinate, cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome | Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome | ALIAS | 0.90 |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| decitabine | Drug | Decitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| omacetaxine mepesuccinate | Drug | Omacetaxine Mepesuccinate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cytarabine, omacetaxine mepesuccinate, decitabine)
- description
- INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: cytarabine
- Drug: omacetaxine mepesuccinate
- Drug: decitabine
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups
- timeFrame
- Up to 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are not eligible for standard induction chemotherapy (or any standard therapy known to be life prolonging) because of poor performance status, significant tissue comorbidities, or unfavorable risk of disease * Have an unequivocal histologic diagnosis of acute myeloid leukemia (AML) (including secondary AML) * No prior therapy for AML except hydroxyurea to control counts * Must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Subjects with the diagnosis of acute promyelocytic leukemia (t\[15;17\]) * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug * Patients with sickle cell disease and sickle cell crisis * Received an investigational agent for another disease within 30 days prior to enrollment * The patient has an uncontrolled and active infection that would preclude study conduct and assessment
References
Publications (0)
Data not yet available
No reference posted for this study.