Description:
The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for
consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first
complete remission following induction with cytarabine and an anthracycline, and also to
assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and
older with acute AML in first complete remission following 3 consolidation courses with
omacetaxine.
Title
- Brief Title: Omacetaxine for Consolidation and Maintenance
- Official Title: Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study
Clinical Trial IDs
- ORG STUDY ID:
IRB00057844
- SECONDARY ID:
Winship2176-11
- NCT ID:
NCT01873495
Conditions
- Acute Myelogenous Leukemia (AML)
Interventions
Drug | Synonyms | Arms |
---|
Omacetaxine | Synribo | Omacetaxine: Consolidation/Maintenance |
Purpose
The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for
consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first
complete remission following induction with cytarabine and an anthracycline, and also to
assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and
older with acute AML in first complete remission following 3 consolidation courses with
omacetaxine.
Trial Arms
Name | Type | Description | Interventions |
---|
Omacetaxine: Consolidation/Maintenance | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of AML including de novo, secondary, or with an antecedent hematologic
disorder (AHD) according to the World Health Organization (WHO) criteria.
2. Age ≥ 55 years.
3. Patient eligible for standard induction chemotherapy based on Eastern Cooperative
Oncology Group (ECOG) performance status and vital organ function at the discretion of
the treating physician.
4. Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine)
are eligible.
5. Provide signed written informed consent.
6. Be able to comply with study procedures and follow-up examinations.
7. Be non-fertile or agree to use birth control during the study through the end of last
treatment visit.
8. Adequate renal and hepatic function at the time of second registration:
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
and
- Serum creatinine ≤ 1.2 x ULN.
9. ECOG performance ≤ 2 at the time of second registration.
10. Patients with a history of carcinoma in remission, on no therapy or on hormonal
therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are
included in the study.
Exclusion Criteria:
1. Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB]
classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic
acid receptor alpha [RARa] and variants).
2. Prior treatment with omacetaxine.
3. Relapsed or refractory AML.
4. Investigational agent received within 30 days prior to the first dose of study drug.
If received any investigational agent prior to this time point, drug-related
toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
5. Psychiatric disorders that would interfere with consent, study participation, or
follow-up.
6. Systemic fungal, bacterial, viral, or other infection not controlled (defined as
exhibiting ongoing signs/symptoms related to the infection and without improvement,
despite appropriate antibiotics or other treatment).
7. Any other severe concurrent disease, or have a history of serious organ dysfunction or
disease involving the heart, kidney, liver, or other organ system that may place the
patient at undue risk to undergo the proposed therapy. This includes uncontrolled
hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia
have been reported (using continuous infusion at higher doses of omacetaxine).
8. Active carcinoma requiring systemic chemotherapy or radiation therapy.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 55 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease Status Assessment Prior to Each Consolidation Cycle |
Time Frame: | 14 days |
Safety Issue: | |
Description: | Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission). |
Secondary Outcome Measures
Measure: | Consolidation Toxicities |
Time Frame: | 12 weeks |
Safety Issue: | |
Description: | Toxicities will be monitored by history, physical examination, and laboratory monitoring (CBC, serum chemistries to include renal and liver function tests) obtained weekly during consolidation and monthly during maintenance according to standard of care (Appendices C and D). Toxicity will be assessed according to the NCI Common Toxicity Criteria Version 4.0 (available at the NCI web site http://ctep.cancer.gov/reporting/ctc.html). |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Emory University |
Last Updated
September 24, 2019