drugset / Trial / NCT06758037
Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
NaSingle-groupOpen-labelTreatment
Summary
To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.
Timeline
- Start
- 2025-01-15
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
Publications
- Results Poddubnaya IV, Alekseev SM, Kaplanov KD, Lukavetskyy LM, Rekhtman GB, Dolai TK, Attili VSS, Bermudez CD, Isaev AA, Chernyaeva EV, Ivanov RA. Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: An international multicenter randomized trial. Hematol Oncol. 2020 Feb;38(1):67-73. doi: 10.1002/hon.2693. Epub 2020 Jan 13.
- Results Shi Y, Song Y, Qin Y, Zhang Q, Han X, Hong X, Wang D, Li W, Zhang Y, Feng J, Yang J, Zhang H, Jin C, Yang Y, Hu J, Wang Z, Jin Z, Su H, Wang H, Yang H, Fu W, Zhang M, Zhang X, Chen Y, Ke X, Liu L, Yu D, Chen G, Wang X, Jin J, Sun T, Du X, Cheng Y, Yi P, Zhao X, Ma C, Cheng J, Chai K, Luk A, Liu E, Zhang X. A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma. J Hematol Oncol. 2020 Apr 16;13(1):38. doi: 10.1186/s13045-020-00871-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | 30 mg | — |
| Subject | Tucidinostat | Small molecule | 150 mg | — |
| Background | Lenalidomide | Other / unclassified | 10 mg | — |
| Background | Lenalidomide | Other / unclassified | 25 mg | — |
| Background | Zebtorizumab | Unknown | 375 mg/m2 | — |