drugset / Trial / NCT03742323
REALIB-LLA-2017: Idelalisib in Patients With Acute Lymphoblastic Leukemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idelalisib | Small molecule | 100 mg | — |
| Subject | Idelalisib | Small molecule | 150 mg | — |
| Subject | Idelalisib | Small molecule | 200 mg | — |
| Subject | Idelalisib | Small molecule | 300 mg | — |