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

NCT02337829 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-08

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Acerta Pharma BV

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-12
Primary Completion
2020-06-26
Completion
2025-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02337829 on ClinicalTrials.gov