A Phase Ib Study of the Combination of Venetoclax With Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
Summary
This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: * Venetoclax * Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine
Description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and drug combination and also tries to define the appropriate dose of the investigational drug and drug combination to use for further studies. "Investigational" means that the drug and drug combination is being studied. The FDA (the U.S. Food and Drug Administration) has not approved Venetoclax for this specific disease, but it has been approved for other uses. Venetoclax is an inhibitor of Bcl-2. Bcl-2 is critical for keeping cancer cells alive. By inhibiting Bcl-2, venetoclax promotes cance…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell) * Bone marrow involvement with ≥20% lymphoblasts * Age ≥ 60 Years OR * Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens * Bone marrow involvement with ≥5% lymphoblasts * Age ≥ 18 Years * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Refer to Appendix D) * Adequate organ function * Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gi…
Interventions
- DrugVenetoclax
Venetoclax is an inhibitor of Bcl-2. Bcl-2 is critical for keeping cancer cells alive. By inhibiting Bcl-2, venetoclax promotes cancer cell death.
- DrugStandard Chemotherapy
Standard treatment of chemotherapy is administered
Locations (5)
- University of ChicagoChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- MD Anderson Cancer CenterHouston, Texas
- Intermountain LDS HospitalSalt Lake City, Utah