NCT05180097

Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma

A Randomized Phase II Study of Pembrolizumab and Brentuximab Vedotin Versus GDP, Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.

Detailed description

Treatment given to participants whose disease has not responded to (refractory) or returned (relapsed) after previous treatment is known as salvage treatment. The standard of care for participants who are not in a study is salvage treatment with gemcitabine, dexamethasone and cisplatin (GDP). This treatment can reduce symptoms and may stop the lymphoma from growing for a few months or longer. This standard treatment is approved by Health Canada We are doing this study because we want to find out if treatment with Pembrolizumab and Brentuximab vedotin is better or worse than the standard of care for this type of cancer, classical Hodgkin lymphoma. The standard of care is defined as care most people get for your cancer.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000mg/m2 IV, 30 mins D1, D8
DRUG	Dexamethasone	40mg daily PO, D1-D4
DRUG	Cisplatin	75mg/m2 IV, 1 hour, D1
DRUG	Brentuximab vedotin	1.8 mg/kg IV, 30 mins, Q21 days
DRUG	Pembrolizumab	200mg IV, 30 mins, Q 21 days

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-01-06
• Last updated: 2026-02-02

Locations

18 sites across 2 countries: Australia, Canada