Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pembrolizumab plus Chemotherapy (ICE or DHAP).
- Who it may be relevant to
- Registry conditions: Classical Hodgkin Lymphoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma
Overview
The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).
Interventions
- Drug Pembrolizumab plus Chemotherapy (ICE or DHAP)
Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP
Primary outcome measures
- Complete Metabolic Response Rate (CMR) [Time frame: after completion of P+chemotherapy, an average of 3 months]
Eligibility criteria
Inclusion criteria
- Histologically confirmed first relapse of cHL or primary refractory cHL
Exclusion criteria
- Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- 1st Department of Medicine, Cologne University Hospital — Cologne
Identifiers
NCT: NCT04838652 · Uni-Koeln-3942