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

Sponsor
Canadian Cancer Trials Group
Study ID
NCT05180097
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jan 6, 2022
Start date
Nov 1, 2022
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: GDP
  • Active Comparator: Brentuximab vedotin + Pembrolizumab

Primary Outcome Measure

Complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy [ Time Frame: 52 months ]

Central Contacts

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