drugset / Trial / NCT05244642
A Phase III Study to Evaluate the Efficacy and Safety of Penpulimab in the Relapsed and Refractory Classical Hodgkin's Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, randomized, phase 3 trial to evaluate the efficacy of Penpulimab vs. standard chemotherapy selected by investigator in patients with relapsed or refractory classic Hodgkin's lymphoma.
Timeline
- Start
- 2022-02-15
- Primary completion
- 2025-12-30
- Completion
- 2026-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | — |
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Comparator | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 2 mg/m2 | — |
| Comparator | Dexamethasone | Small molecule | 10 mg/m2 | — |
| Comparator | Dexamethasone | Small molecule | 40 mg | — |
| Comparator | Doxorubicin | Other / unclassified | 15 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 40 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 60 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 65 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Ifosfamide | Small molecule | 2 mg/m2 | — |
| Comparator | Ifosfamide | Small molecule | 5 mg/m2 | — |
| Comparator | Ifosfamide | Small molecule | 1 g/kg | — |
| Comparator | Ifosfamide | Small molecule | 1.33 g/kg | — |
| Comparator | Methylprednisolone | Other / unclassified | 500 mg | — |
| Comparator | Mitoxantrone | Small molecule | 8 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 100 mg/m2 | — |
| Subject | Penpulimab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | Prednisone | Other / unclassified | 100 mg | — |
| Comparator | Vinorelbine | Small molecule | 20 mg/m2 | — |