Omacetaxine for Consolidation and Maintenance
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|ClinicalTrials.gov Identifier: NCT01873495|
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia (AML)||Drug: Omacetaxine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
|Experimental: Omacetaxine: Consolidation/Maintenance||
Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.
Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles
Other Name: Synribo
- 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). [ Time Frame: 14 days ]
- Assessment of disease status [ Time Frame: 1 month ]Bone marrow biopsy and aspirate will be obtained.
- Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance. [ Time Frame: 3 months ]
- Toxicities will be monitored by history, physical examination, and laboratory monitoring-during maintenance. [ Time Frame: 24 weeks ]
- Toxicities will be monitored by history, physical examination, and laboratory monitoring-during consolidation. [ Time Frame: 12 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873495
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Martha L. Arellano, MD||Emory University|