Phase II Study of CPX-351 in Combination With Venetoclax in Patients With Acute Myeloid Leukemia (AML)
M.D. Anderson Cancer Center
Summary
This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Description
PRIMARY OBJECTIVE: I. To assess the efficacy (complete remission \[CR\], complete remission without blood count recovery \[CRi\], complete remission without platelet recovery \[CRp\]) of liposome-encapsulated daunorubicin-cytarabine (CPX-351) in combination with venetoclax in patients with acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. To assess safety of CPX-351 in combination with venetoclax in patients with AML. II. To assess the event free survival (EFS) and overall survival (OS) in patients with AML. EXPLORATORY OBJECTIVE: I. To explore biomarkers of response and resistance…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * For the lead in phase: Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible. Patients who have had prior treatment with venetoclax will be allowed to participate in the lead in phase and cohort A * For the dose expansion cohort A (relapsed/refractory \[R/R\] AML): Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible * For the dose expansion cohort B (de novo AML): Patients \>= 18 years to 69 years of age; patients in this cohort must have received no prior therapy for AML * Prior ther…
Interventions
- DrugLiposome-encapsulated Daunorubicin-Cytarabine
Given IV
- DrugVenetoclax
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas