Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML
The purpose of this study is to learn more about the experimental study drug, CPX-351, in patients who are newly diagnosed with high risk (secondary) Acute Myelogenous Leukemia (AML) and have not received any treatment for the disease. CPX-351 is a formulation of a fixed combination of the two anti-tumor drugs, cytarabine and daunorubicin
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : CPX-351
- drug : 7+3 (cytarabine and daunorubicin)
Phase: Phase 3
Ages Eligible For Study:
- Ability to understand and voluntarily give informed consent - Age 60-75 years at the time of diagnosis of AML - Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) - Confirmation of: - Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease - AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS - AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL - De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Able to adhere to the study visit schedule and other protocol requirements - Laboratory values fulfilling the following: - Serum creatinine < 2.0 mg/dL - Serum total bilirubin < 2.0 mg/dL, patients with Gilbert's Syndrome should contact the medical monitor - Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN Note: If elevated liver enzymes, above the ULN, are related to disease; contact medical monitor to discuss. - Cardiac ejection fraction ? 50% by echocardiography or MUGA - Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.