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A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies

NCT03198650 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-10-09

No results posted yet for this study

Summary

This is a multicenter, open-label Phase 1 study of acalabrutinib, a selective and irreversible Bruton's tyrosine kinase inhibitor, in Japanese adult patients with advanced B-cell malignancies. This study is divided into 3 parts: Part 1 (dose-confirmation phase), Part 2 (dose-expansion phase) and Part 3 (dose-confirmation phase for combination therapy).

Conditions

  • Part1: Advanced B-cell Malignancies
  • Part2: r/rCLL and r/rMCL
  • Part3: Untreated CLL

Interventions

DRUG

Acalabrutinib

Acalabrutinib

DRUG

Obinutuzumab

Obinutuzumab

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2022-10-27
Completion
2025-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03198650 on ClinicalTrials.gov