Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-047
Prinicipal Investigator
Claxton, David
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
EA9152
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
Objective
Primary Endpoints Phase I:

To determine the maximum tolerated dose of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL.

Safety assessment and toxicity characterization after treatment of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL.

Primary Endpoints Phase II:

To determine the preliminary efficacy of venetoclax in combination with liposomal vincristine to induce CR by day 70 in patients with relapsed or refractory T-cell and B-cell ALL.

Secondary Endpoints Phase II:

To determine the progression free survival, overall survival and toxicity after the combination treatment in patients with relapsed or refractory T-cell and B-cell ALL.
Applicable Disease Sites
Leukemia, other
Status
Open
Participating Institutions
Hershey Medical Center