drugset / Trial / NCT03932331
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-04-29
- Primary completion
- 2022-12-22
- Completion
- 2026-06-24
Publications
- Yang 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.
- Song 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | 100 mg | Oral |