A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Phase 1

• Conditions: High Risk Chronic Lymphocytic Leukemia; MedDRA version: 19.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005317-68-FR
• Lead Sponsor: Acerta Pharma, BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-28
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1-Prior diagnosis of CLL that meets published diagnostic criteria (Hallek 2008)
2-Must have received = 1 prior therapy for CLL and not be appropriate for treatment or retreatment with purine analogue-based therapy
3-Intolerant of ibrutinib, defined as the subject has discontinued ibrutinib therapy due to Grade 3 or 4 AEs that persisted in spite of optimal supportive care measures OR patients who had Grade 2 AEs related to ibrutinib therapy, in spite of optimal supportive care measures, that persisted for = 2 weeks or that recurred = 2 times whether dose was reduced or discontinued.
4-ECOG performance status of = 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1-Ongoing Grade 3 or 4 AE attributed to ibrutinib therapy. Note: Patients may be eligible for enrollment once the ibrutinib-related AE improves to Grade = 2.
2-Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
3-Prior exposure to a BCL-2 inhibitor (eg, ABT-199).
4-Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for = 2 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified