drugset / Trial / NCT03808610

Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

NCT03808610

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of venetoclax and how well it works in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia that has not responded to treatment or that has come back. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, including vincristine, cyclophosphamide, dexamethasone, rituximab, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with low-intensity chemotherapy may work better in treating patient with B- or T-cell acute lymphoblastic leukemia.

Timeline

Start
2019-04-03
Primary completion
2026-05-05
Completion
2026-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 200 mg Oral
Subject Venetoclax Small molecule 400 mg Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Dexamethasone Small molecule Intravenous
Background Methotrexate Small molecule Intravenous
Background Nelarabine Small molecule Intravenous
Background Pegaspargase Protein / enzyme biologic Intravenous
Background Prednisone Other / unclassified Oral
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule Intravenous