First relapse or primary refractory of classical Hodgkin lymphoma
Conditions
Brief summary
Complete metabolic response (CMR) rate, defined as the proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP).
Detailed description
Complete metabolic response rate after 2 cycles of combination therapy, Remission status after end of treatment including pembrolizumab consolidation, Proportion of patients receiving HDCT and autologous stem-cell transplantation (ASCT), Progression-free and overall survival after 1 and 2 years, Event-free survival after 1 and 2 years, defined as progression-free survival with the application of HDCT and ASCT counting as additional failure events, Adverse events, Patient-reported outcome (PRO-CTCAE, fatigue and quality of life)
Interventions
DRUGETOPOSIDE PHOSPHATE
DRUGCYTARABINE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGIFOSFAMIDE
DRUGDEXAMETHASONE
DRUGCARBOPLATIN
DRUGCISPLATIN
Sponsors
University Of Cologne
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete metabolic response (CMR) rate, defined as the proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP). | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete metabolic response rate after 2 cycles of combination therapy, Remission status after end of treatment including pembrolizumab consolidation, Proportion of patients receiving HDCT and autologous stem-cell transplantation (ASCT), Progression-free and overall survival after 1 and 2 years, Event-free survival after 1 and 2 years, defined as progression-free survival with the application of HDCT and ASCT counting as additional failure events, Adverse events, Patient-reported outcome (PRO-CTCAE, fatigue and quality of life) | — |
Countries
Germany
Outcome results
None listed