{"entity":{"id":"nct03932331","kind":"trial","name":"Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malign","aka":[],"tldr":"A phase 1/2 trial of Acalabrutinib in mantle cell lymphoma, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies is a phase 1/2 interventional study registered as NCT03932331 by AstraZeneca, with 105 participants enrolled, started 2020-04-29 and due to reach its primary completion in 2022-12-22. Interventions recorded: Acalabrutinib. Conditions listed: 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. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03932331","url":"https://clinicaltrials.gov/study/NCT03932331"}],"tags":["ctgov-ingest"],"related":[],"cancers":["mantle-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["acalabrutinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03932331","phase":"1/2","setting":"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","sponsor":"AstraZeneca","started":"2020-04-29","startedType":"actual","yearReported":2025,"enrolled":105,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase II: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR)","primary":true,"unit":"%","arms":[{"name":"Phase II MCL","n":34,"value":82.4,"note":"95% CI 65.5 to 93.2; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication"},{"name":"Phase II CLL","n":60,"value":86.7,"note":"95% CI 75.4 to 94.1"}],"source":"https://clinicaltrials.gov/study/NCT03932331?tab=results"},{"endpoint":"Phase II: Percentage of Participants With Overall Survival (OS) at Month 6","unit":"%","arms":[{"name":"Phase II MCL","n":34,"note":"The OS is not mature to report median and 95% confidence interval at time of analysis.; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication"},{"name":"Phase II CLL","n":60,"value":96.7,"note":"95% CI 87.3 to 99.2"}],"source":"https://clinicaltrials.gov/study/NCT03932331?tab=results"}]},"route":"/trials/nct03932331/","neighbours":{"cancer":[{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"acalabrutinib","kind":"drug","name":"Acalabrutinib","route":"/drugs/acalabrutinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}