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

NCT03932331 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-04-20

Study results available
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Summary

This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.

Conditions

  • Phase I: Relapsed or Refractory B-cell Malignancies
  • Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma
  • Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

DRUG

Acalabrutinib

Acalabrutinib 100 mg orally twice daily

Sponsors & Collaborators

Principal Investigators

  • Jun Zhu, Prof · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2022-12-22
Completion
2026-06-24

Countries

  • China

Study Locations

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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 NCT03932331 on ClinicalTrials.gov