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Pembro-FLASH - Phase II trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classic Hodgkin Lymphoma

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501458-13-01
Acronym
Uni-Koeln-4938
Enrollment
40
Registered
2025-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Stage of Classic Hodgkin Lymphoma

Brief summary

1-year PFS estimate

Detailed description

Adverse events, Target number of P-BrECADD cycles per 100 participants, Remission status after 1x P (PET-1), 1x P + 2x P-BrECADD (PET-3) and after completion of PET-guided chemo-immunotherapy (PET-5 or PET-7, respectively), Overall survival after one year, Patient-reported outcomes (PRO-CTCAE, Fatigue, QLQ-C30 and Quality of Life)

Interventions

DRUGDACARBAZINE CITRATE
DRUGADCETRIS 50 mg powder for concentrate for solution for infusion.
DRUGETOPOSIDE
DRUGDOXORUBICIN
DRUGDEXAMETHASONE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCYCLOPHOSPHAMIDE

Sponsors

University Of Cologne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
1-year PFS estimate—

Secondary

MeasureTime frame
Adverse events, Target number of P-BrECADD cycles per 100 participants, Remission status after 1x P (PET-1), 1x P + 2x P-BrECADD (PET-3) and after completion of PET-guided chemo-immunotherapy (PET-5 or PET-7, respectively), Overall survival after one year, Patient-reported outcomes (PRO-CTCAE, Fatigue, QLQ-C30 and Quality of Life)—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026