A Phase II Study of CPX-351 for Treatment of AML or Higher Risk MDS Relapsed or Refractory to Prior Therapy With Hypomethylating (HMA) Agent
This phase II clinical trial studies how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-35, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Stanford is now accepting new patients for this trial.
- drug : liposomal cytarabine-daunorubicin CPX-351
- other : laboratory biomarker analysis
Phase: Phase 2
Ages Eligible For Study:
- Ability to understand and voluntarily give informed consent - Age ? 60 - Pathological diagnosis of AML (by WHO criteria) or higher risk MDS (includes int-2 and high risk MDS by IPSS) along with one of the following: - Patients with de novo or secondary MDS with progression/refractoriness after HMA treatment who have not transformed to AML - Patients with MDS and prior HMA treatment for MDS who transform to AML - Patients with AML who are refractory/relapsed after HMA therapy for their AML are eligible - Life expectancy > 1 month - 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 ? 2.5 mg/dL. Note, patients with Gilbert's syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS. Patients with Gilbert's syndrome are included if their total bilirubin is ? 2 times their baseline total bilirubin. - Serum alanine aminotransferase or aspartate aminotransferase < 3 times ULN - Cardiac ejection fraction ? 45% by echocardiography (transthoracic echocardiography) or MUGA scan - Patients with second malignancies may be eligible at discretion of PI given acute life threatening nature of untreated AML or higher risk MDS. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are also eligible.