drugset / Trial / NCT05820841
Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
Phase 3
Recruiting
330 enrolled
Saarland University
AstraZeneca · collabSaarland University Medical Center · collabUniversity Hospital Giessen and Marburg · collabUniversity Hospital Regensburg · collabUniversity of Leipzig · collabWuerzburg University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib. Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.
Timeline
- Start
- 2023-06-07
- Primary completion
- 2029-02
- Completion
- 2029-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | 100 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 400 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Prednisolone | Other / unclassified | 40 mg/m2 | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Vincristine | Small molecule | 1 mg | Intravenous |