At a glance
ClinicalIndex Comparison RecordPhase 2Active· 105 enrolled
Drug / intervention
Acalabrutinibdrug
Likely dose
Acalabrutinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Acalabrutinib for Phase I: Relapsed or Refractory B-cell Malignancies and 2 related conditions. Active but no longer recruiting, targeting 105 participants across 23 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhase 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
CountriesChina
Collaborators--
Timeline
Phase 2ActiveOverdue
2020202120222023202420252026
First PostedApr 2019
Enrollment StartApr 2020
Primary CompletionDec 2022
Study CompletionJun 2026
TodayJul 2026
First PostedApr 30, 2019
Enrollment StartApr 29, 2020
Primary CompletionDec 22, 2022
Study CompletionJun 24, 2026
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.2 years ago
Interventions
Acalabrutinibdrug
Acalabrutinib 100 mg orally twice daily