Study of Acalabrutinib in Chinese Adult Subjects with Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or other B-cell Malignancies

Study identifier:D8220C00007

ClinicalTrials.gov identifier:NCT03932331

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects with Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or other B-cell Malignancies

Medical condition

Phase I: Relapsed or Refractory B-cell Malignancies

Phase

Phase 1/2

Healthy volunteers

No

Study drug

Acalabrutinib

Sex

All

Actual Enrollment

105

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Apr 2020
Primary Completion Date: 22 Dec 2022
Estimated Study Completion Date: 24 Jun 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria