Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML
Trial Parameters
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Brief Summary
To compare the event-free survival at 2 years of CPX-351 vs. conventional care regimens before allogeneic blood cell transplantation as first line treatment in patients with higher risk MDS and oligoblastic AML.
Eligibility Criteria
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 fo