NCT02296918

Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL

A Phase 1b Study of ACP-196 in Combination With Obinutuzumab for Patients With Relapsed / Refractory or Untreated CLL/SLL/PLL

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and preliminary efficacy of acalabrutinib in combination with obinutuzumab in 4 separate cohorts of participants.

Detailed description

A Phase 1b Study of ACP-196 in Combination with Obinutuzumab for Participants with Relapsed/Refractory or Untreated chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL)/ prolymphocytic leukemia (PLL). Study started with two cohorts, on Acalabrutinib and Obinutuzumab, cohort 1 for relapsed or refractory participants and cohort 2 for treatment naïve participants. Then for longer survival data and combination therapy, two new cohorts added to the study, cohort 3 with relapsed or refractory participants on Acalabrutinib, Rituximab and Venetoclax, and cohort 4 with treatment naïve participants on Acalabrutinib, Obinutuzumab and Venetoclax. Primary endpoints: For Cohorts 1 and 2, the ORR (PR or better) at the 12-month response assessment will be calculated and 95% exact binomial confidence interval (CIs) will be provided. For Cohorts 1 to 4, toxicities will be tabulated by type and grade using NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) version 4.03 criteria or higher and displayed in summary form. Currently, study is in maintenance phase and we don't expect a major change in the near future.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Prolymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	acalabrutinib	Participants will receive oral acalabrutinib in Cohorts 1, 2, 3, and 4. The details are mentioned in the cohort description.
DRUG	Obinutuzumab	Participants will receive intravenous obinutuzumab in Cohorts 1, 2, and 4. The details are mentioned in the cohort description.
DRUG	Venetoclax	Participants will receive oral venetoclax in Cohorts 3 and 4. The details are mentioned in the cohort description.
DRUG	Rituximab	Participants will receive intravenous rituximab in Cohort 3. The details are mentioned in the cohort description.

Timeline

• Start date: 2014-12-22
• Primary completion: 2021-08-20
• Completion: 2025-10-22
• First posted: 2014-11-21
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States