A Phase II Study of Omacetaxine (OM) in Patients with Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) post Hypomethylating Agent (HMA) Failure
The goal of this clinical research study is learn if omacetaxine can help to control myelodysplastic syndrome (MDS). The safety of this drug will also be studied.
Disease Group: Leukemia
Treatment Agent: Omacetaxine Mepesuccinate
Treatment Location: Only at MDACC
Sponsor: TEVA Pharmaceuticals
Primary Objectives: To assess overall survival and To assess overall response rate (ORR) Secondary objectives To assess duration of response To assess relapse-free survival To assess the safety profile
IRB Review and Approval Date: 05/18/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Age >/= 18 years
2) Diagnosis of MDS confirmed within 10 weeks prior to study entry according to WHO criteria. Patients are either not eligible for or choose not to proceed with a stem cell transplant.
3) MDS classified as follows: RAEB-1 (5%-9% BM blasts); RAEB-2 (10%-19% BM Blasts); CMML (5%-19% BM blasts); RAEB-t (20%-29% BM blasts) AND/OR by IPSS: intermediate-1 and high risk patients.
4) No response, progression, or relapse (according to 2006 IWG criteria) following at least 4 cycles of either azactidine or decitabine, which were completed within the last 2 years - AND/OR - intolerance to azacitidine or decitabine defined as drug-related >/= grade 3 hepatic or renal toxicity leading to treatment discontinuation during the preceding 2 years.
5) Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
6) Willing to adhere to and comply with all prohibitions and restrictions specified in the protocol.
7) Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.)
1) Uncontrolled intercurrent illness including, but not limited to,
symptomatic congestive heart failure, unstable angina pectoris, or
2) Active infection not adequately responding to appropriate antibiotics (i.e. ongoing temperatures of >/= 38 degree Celsius).
3) Total bilirubin >/= 1.5 mg/dL and not related to hemolysis or Gilbert's disease. Patients with total bilirubin >/= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirect.
4) Alanine transaminase (ALT/SGPT) or aspartate transaminase (AST/SGOT) >/= 2.5 x the upper limit of normal.
5) Serum creatinine > 1.5 mg/dL.
6) Female patients who are pregnant or lactating.
7) Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study.
8) Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.
9) Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy.
10) Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, G-CSF, GM-CSF, procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient.
11) Psychiatric illness or social situation that would limit the patient's ability to comply with study requirements.
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