NCT03742323

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

Phase I-II Unmasked, Non-randomized Study Evaluating the Role of Idelalisib in Patients With Acute Lymphoblastic Leukemia (ALL) That is Relapsing or Refractory to Other Treatments, and in Older Patients With ALL for Whom Conventional Treatments Are Not Recommended

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase I-II multi-site, exploratory, interventional, unmasked, non-randomized, single arm clinical trial. A single drug will be administered in four different, increasing doses to four consecutive cohorts. The first phase of the study will focus on determining the most effective and tolerated dose of the study drug. The second phase will follow patients to the end to evaluate the safety of the drug. The dose escalation will be decided by the Study Coordinator, who will evaluate and assess each cohort. Once the cohort of 6 patients is complete, the Coordinator will evaluate patients and, based on the tolerability and efficacy obtained, will decide whether to proceed with the dose escalation, or whether to end the trial The study will remain open until the overall number of participants is achieved; §progressive dose increases (PI) will be discontinued if dose-limiting toxicity (DLT) is observed in more than two patients in the previous cohort, \*PI of the dose will only continue (for the third cohort) if at least two patients in the first two cohorts achieve the overall response rate (ORR), that is, complete response (CR) at four weeks from initiation of treatment; \*\* the study will only move on to the fourth cohort if CR is achieved in at least one of the six patients in the third cohort at four weeks from initiation of treatment; \*\*\*microscopy/cytofluorometry; \*\*\*\*complete blood count, microscopy, biochemistry; \*\*\*\*\*as long as there is no relapse, treatment will continue after the end of the study (planned for 24 months after the start of recruitment); AE, adverse events

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Idelalisib	Idelalisib Dose: 100, 150, 200 or 300 mg (in four cohorts of six patients each).

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-06-02
• Completion: 2020-06-02
• First posted: 2018-11-15
• Last updated: 2021-09-05

Locations

12 sites across 1 country: Spain