A Phase 1 interventional study of Omacetaxine and Decitabine in Leukemia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 2 groups of up to 6 participants (combined) will be enrolled in the Phase 1 portion of the study, and up to 60 participants will be enrolled in Phase 2.
If you are enrolled in Phase 1, the dose of decitabine you receive will depend on when you joined this study. If the first group of participants to receive decitabine has intolerable side effects, a second group will receive a lower dose.
If you are enrolled in Phase 2, you will receive decitabine at the highest dose that was tolerated in Phase 1.
All participants will receive the same dose level of omacetaxine.
Study Drug Administration:
Each cycle is 28 days.
Omacetaxine will be given as an injection under your skin 2 times each day, 12 hours apart (+/- 3 hours) on Days 1-3 of every cycle.
Decitabine will be given by vein over about 1 hour on Days 1-5 of every cycle.
Study Visits:
Every week (+/- 2 days), blood (about 2-3 teaspoons) will be collected for routine tests. If the disease appears to get better, this blood will only be drawn every 2-4 weeks while you are still receiving the study drugs, and every 4 to 8 weeks after that as long as you are on study. If you live far from the clinic, this blood and urine can be collected at a clinic close to your home, and the results will be reported to the study doctor.
At the beginning of every cycle, you will have a physical exam.
At Week 3 (+/- 7 days) and then every 4 weeks after that (+/- 7 days), you may (based on the results of your blood tests) have a bone marrow aspirate/biopsy collected to check the status of the disease and for cytogenetic testing.
Length of Study:
You may continue taking the study drugs for up to 3 years or as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow Up:
You will have follow-up visits every 3-6 months for up to 5 years after you stop receiving the study drugs. At these visits, you will have a physical exam. If you cannot come to the clinic, you may just be called by the study staff and asked about your health. These calls should last about 5-10 minutes.
This is an investigational study. Omacetaxine is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). Its use in this study is investigational. Decitabine is FDA approved and commercially available for the treatment of MDS.
The study doctor can explain how the study drugs are designed to work.
Up to 66 participants will be enrolled in this study. All will take part at MD Anderson.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 2 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle. Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle. Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.
Drug: Omacetaxine · Drug: Decitabine
Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.
Also known as: Synribo, Homoharringtonine
Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle. Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.
Also known as: Dacogen
Safe Dose Combination of Omacetaxine (OM) and Decitabine (DAC)
Safe dose defined as highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during first treatment cycle. DLT defined as clinically significant Grade 3 or 4 adverse event or abnormal laboratory value according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study.
Time frame: 28 days
Complete Response Rate (CRR)
Complete response rate (CRR) is defined as CR or CR with incomplete platelet recovery (CRp).
Time frame: 8 weeks
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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