NCT02337829

Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

A Phase II Study Using ACP-196 (Acalabrutinib) in Patients With Relapsed/Refractory and Treatment-naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Antitumor Response.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Detailed description

To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib (Arm A)	* A1a) acalabrutinib, dose A daily: biopsy (T) schedule W; * A1b) acalabrutinib, dose A daily: biopsy (T) schedule V. * A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y; * A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z
DRUG	Acalabrutinib (Arm B)	B1c) acalabrutinib, dose A daily: biopsy (U) schedule W; • B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.

Timeline

• Start date: 2015-01-12
• Primary completion: 2020-06-26
• Completion: 2025-10-31
• First posted: 2015-01-14
• Last updated: 2026-01-08
• Results posted: 2021-08-18

Locations

1 site across 1 country: United States