Trials / Active Not Recruiting
Active Not RecruitingNCT02213926
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Acerta Pharma BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
Detailed description
This clinical trial is a Phase 2, multicenter, (approximately 70 global centers), open-label study in subjects with histologically documented MCL, who have relapsed after, or were refractory to, ≥ 1 (but not \> 5) prior treatment regimens. Subjects will be enrolled and will take 100 mg of acalabrutinib twice per day (BID) in repeated 28-day cycles. Treatment with acalabrutinib may be continued until disease progression or an unacceptable drug-related toxicity occurs. Dose modification provisions are provided in the study protocol. All subjects will have hematology, chemistry, and urinalysis safety panels done at screening. Once dosing commences (Day 1), all subjects will be evaluated for safety, including serum chemistry and hematology, once weekly for the first 4 weeks, every 2 weeks in Cycle 2, every 4 weeks in Cycles 3 to 12, and every 24 weeks thereafter. PK/PD testing will be done in Cycles 1 and 2. Tumor assessments will be completed at 8- to 24-week intervals during the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACP-196 (acalabrutinib) |
Timeline
- Start date
- 2015-03-02
- Primary completion
- 2020-12-04
- Completion
- 2026-09-09
- First posted
- 2014-08-12
- Last updated
- 2026-02-10
- Results posted
- 2018-10-19
Locations
58 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Italy, Netherlands, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02213926. Inclusion in this directory is not an endorsement.