drugset / Trial / NCT03742323

REALIB-LLA-2017: Idelalisib in Patients With Acute Lymphoblastic Leukemia

NCT03742323

Phase 1/2 Terminated 6 enrolled PETHEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

This study will attempt to confirm the hypothesis that Idelalisib may represent a new therapeutic alternative for patients with ALL in a set of particularly complex scenarios: relapsed, refractory to conventional treatments, and old age. For this reason, the primary objective is the overall response rate \[ORR, defined as complete response (CR) or CR with partial hematologic recovery (CRh) and response duration (RD) in adult patients with relapsed or refractory ALL, or in adult ALL patients who are not suitable for treatment with conventional therapies.

Timeline

Start
2018-07-01
Primary completion
2020-06-02
Completion
2020-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Idelalisib Small molecule 100 mg
Subject Idelalisib Small molecule 150 mg
Subject Idelalisib Small molecule 200 mg
Subject Idelalisib Small molecule 300 mg