drugset
drugset / Trial / NCT02404220

Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

NCT02404220 ↗

Phase 1/2 Terminated 30 enrolled Gilead Sciences
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL). This is a dose escalation study in which after 2 induction cycles participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.

Timeline

Start
2015-05-06
Primary completion
2018-11-16
Completion
2018-12-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Entospletinib Small molecule 200 mg Oral
Subject Entospletinib Small molecule 400 mg Oral
Background Dexamethasone Small molecule 10 mg Oral
Background Dexamethasone Small molecule 20 mg Oral
Background Vincristine Small molecule 0.5 mg Intravenous
Background Vincristine Small molecule 1 mg Intravenous
Background Vincristine Small molecule 2 mg Intravenous

Indications

acute lymphoblastic leukemia