drugset / Trial / NCT07034508
A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab
Timeline
- Start
- 2025-06-20
- Primary completion
- 2027-12-20
- Completion
- 2029-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Polatuzumab Vedotin | Other / unclassified | 1.8 mg/kg | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |