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Acalabrutinib in Relapsed/Refractory CLL Intolerant to Ibrutinib
NCT02717611Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2016
- Primary completion
- Oct 2020
- Countries
- 6
- Sponsor
- Acerta Pharma
- Drugs
- acalabrutinib tablet (Variant 1)
- Conditions
- chronic lymphocytic leukemia (CLL)
01
Overview
Phase 2, open-label, single-arm trial of acalabrutinib tablet (Variant 1) in chronic lymphocytic leukemia (CLL), sponsored by Acerta Pharma. Primary endpoint: Overall Response Rate. Started Mar 2016; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
ACP-196 (acalabrutinib)
Experimental arm receiving Acalabrutinib 100 mg PO BID.
03
Who it enrols
Adults with relapsed/refractory CLL who have received at least one prior therapy, are intolerant to ibrutinib, and have documented disease progression after stopping ibrutinib. Excludes patients with prior BCL-2 inhibitor exposure, significant cardiovascular disease, or active infections.
04
Endpoints
Primary
Overall Response Rate
Secondary
Progression-Free Survival
Duration of Response
Time-to-Next Treatment
Overall Survival
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