An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02213926|
Recruitment Status : Active, not recruiting
First Posted : August 12, 2014
Results First Posted : October 19, 2018
Last Update Posted : May 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma (MCL)||Drug: ACP-196 (acalabrutinib)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma|
|Actual Study Start Date :||March 2, 2015|
|Actual Primary Completion Date :||December 4, 2020|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: ACP-196 (acalabrutinib) Regimen 1
ACP-196 (acalabrutinib) Regimen 1
Drug: ACP-196 (acalabrutinib)
- Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. [ Time Frame: Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year ]The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213926
|Study Director:||Acerta Pharma||1-888-292-9613|