MedTrace Logo

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

NCT03742323 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-09-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Idelalisib

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

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742323 on ClinicalTrials.gov