A Phase IB/II Study of Venetoclax plus Liposomal Vincristine in Patients with Recurrent or Persistent T-Cell or B-Cell Acute Lymphoblastic Leukemia

Full Title

A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (CIRB)

Purpose

Liposomal vincristine is a standard chemotherapy drug for patients with acute lymphoblastic leukemia (ALL). In this study, researchers are assessing the safety and effectiveness of adding the drug venetoclax to liposomal vincristine treatment in patients with T-cell ALL and B-cell ALL that has come back or continues to grow despite prior therapy.

Venetoclax is approved by the FDA to treat patients small lymphocytic lymphoma/leukemia and acute myeloid leukemia. It blocks a protein called Bcl-2, which helps cancer cells survive and resist the effects of anticancer treatments. By blocking Bcl-2, venetoclax could kill ALL cells and/or make them more vulnerable to the effects of other cancer treatments, such as liposomal vincristine.

Venetoclax is taken orally (by mouth) and liposomal vincristine is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have T-cell ALL or B-cell ALL that came back or continues to grow despite prior treatment.
  • At least 2 weeks must pass between the completion of prior chemotherapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.

Protocol

18-511

Phase

I/II

Investigator

Co-Investigators