Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML

Inclusion Criteria

• •Male and female adult patients, 18-75 years of age
• •Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC \<13 Gpt/l) AML up to 29% of bone marrow blasts
• •Availability of BM blast count from central morphology
• •Bone marrow blasts ≥ 5%
• •IPSS score intermediate or high
• •alloHCT intended within the next 6 months
• •ECOG performance status of 0 or 1
• •Signed informed consent
• •Laboratory values fulfilling the following:
• •Serum creatinine \< 2.0 mg/dL
• •Serum total bilirubin \< 2.0 mg/dL
• •Serum alanine aminotransferase or aspartate aminotransferase \< 3 times the ULN
• •Cardiac ejection fraction (LVEF) ≥ 50% by echocardiography
• •Contraception:
• •Female subjects of childbearing potential† must agree to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351. Medically acceptable methods of contraception that may be used by the patient include abstinence, diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, hormonal contraceptives (patients must be stable on hormonal contraceptives for at least the prior 3 months), surgical sterilization, or post-menopausal (≥2 years of amenorrhea). Medically acceptable methods of contraception that may be used by the male partner of a female patient are condom and spermicide or vasectomy (\>6 months prior to Day-1) and are to be used throughout the entire study period and for 6 months following the last dose of CPX-351.
• •Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351 and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
• •Combined oral contraceptive pills are not recommended. It is recommended that during the study two medically accepted methods of contraception (e.g. as hormonal contraceptive methods along with a condom) apply.