Acalabrutinib in patients with Relapsed/Refractory and Treatment naïve deletion 17p CLL/SLL

Study identifier:15-H-0016

ClinicalTrials.gov identifier:NCT02337829

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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.

Medical condition

Chronic Lymphocytic Leukemia

Phase

Phase 2

Healthy volunteers

No

Study drug

Acalabrutinib (Arm A), Acalabrutinib (Arm B)

Sex

All

Actual Enrollment

48

Study type

Interventional

Age

n/a - n/a

Date

Study Start Date: 12 Jan 2015
Primary Completion Date: 26 Jun 2020
Estimated Study Completion Date: 01 Apr 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AcertaPharma

Sponsors

AcertaPharma

Collaborators

NIH

Inclusion and exclusion criteria