Clinical trial · Interventional
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
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
NCT03932331CI-TRIAL-00108752active not recruitingPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma | — | UNRESOLVED | — |
| Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia | — | UNRESOLVED | — |
| Phase I: Relapsed or Refractory B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acalabrutinib
- description
- Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Acalabrutinib
Primary outcomes (19)
- measure
- Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- From the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months.
- description
- An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of acalabrutinib were those with action taken was 'Drug Permanently Discontinued' for acalabrutinib.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Chinese subjects at least 18 years of age at the time of study entry. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 4. Adequate hematological and organ function. 5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy. 6. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14) (q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5). Disease had relapsed after or been refractory to previous treatment. 7. Diagnosis of CLL that meets published diagnostic criteria. Must have received ≥ 1 prior systemic therapies for CLL. 8. Active disease per iwCLL 2018 criteria that requires treatment. (CLL only) 9. Other relapsed/refractory B-cell malignancies without stand of care (phase 1 only). Exclusion criteria 1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject had been disease free for ≥2 years or which would not have limited survival to \<2 years. 2. Significant cardiovascular disease. 3. Known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease. 4. Known history of HIV, serologic status reflecting active hepatitis B or C infection. 5. Major surgery within 4 weeks before first dose of study drugs. 6. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. 7. Required or received anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon). 8. Prior exposure to a BCR or BCL-2 inhibitor. 9. Use of a strong inhibitor or inducer of CYP3A. 10. Breastfeeding or pregnant.
References
Publications (2)
- DERIVEDYang S, Huang H, Zhou K, Zhao X, Han Y, Li L, Wang Y, Liu X, Li J. Acalabrutinib in Chinese patients with relapsed/refractory chronic lymphocytic leukemia: Primary analysis from an open-label, multicenter phase 1/2 trial. Ann Hematol. 2025 Jan;104(1):701-712. doi: 10.1007/s00277-024-05978-4. Epub 2024 Sep 14. PMID 39271521
- DERIVEDSong Y, Li J, Zhou K, Ke X, Cai Z, Zhang H, Yao T, Xia Z, Wang Y, Lai P, Liu X, Zhu J. Phase 1/2 multicenter trial of acalabrutinib in Chinese patients with relapsed/refractory mantle cell lymphoma. Leuk Lymphoma. 2024 May;65(5):647-652. doi: 10.1080/10428194.2024.2310141. Epub 2024 Apr 1. PMID 38557285