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.
Terminated
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| cytarabine | ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside | Treatment (cytarabine, omacetaxine mepesuccinate, decitabine) |
| omacetaxine mepesuccinate | CGX-635, homoharringtonine | Treatment (cytarabine, omacetaxine mepesuccinate, decitabine) |
| decitabine | 5-aza-dCyd, 5AZA, DAC | Treatment (cytarabine, omacetaxine mepesuccinate, decitabine) |
PRIMARY OBJECTIVES:
I. To study the complete response rate following OAG (omacetaxine mepesuccinate, cytarabine)
in newly diagnosed acute myeloid leukemia patients unfit for intensive induction therapy.
II. To assess the toxicity of OAG using the Cancer Therapy Evaluation Program (CTEP) National
Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
SECONDARY OBJECTIVES:
I. To study the disease-free and overall survival of OAG and decitabine in newly diagnosed
acute myeloid leukemia patients unfit for intensive induction therapy.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive cytarabine subcutaneously (SC) twice daily (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 complete response (CR) in the absence
of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients
receive decitabine intravenously (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.
After completion of study treatment, patients are followed up at 30 days, every 3 months for
1 year, every 6 months for 1 year, and then annually thereafter.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Treatment (cytarabine, omacetaxine mepesuccinate, decitabine) | Experimental | 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. |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 65 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated. |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Roswell Park Cancer Institute |
May 9, 2016
