Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma (Pembro-FLASH)

University of Cologne

Status and phase: Begins enrollment this month; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06045195

Uni-Koeln-4938

Details and patient eligibility

About

The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year PFS rate after treatment with one dose of pembrolizumab followed by four to six cycles of chemo-immunotherapy with P-BrECADD, and PET-guided radiotherapy as per standard of care

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• age 18-60
• advanced stage classical Hodgkin Lymphoma
• no previous treatment for cHL

Main Exclusion Criteria:

• Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
• Chemotherapy or radiotherapy in medical history
• Prior or concurrent disease that prevents treatment according to protocol

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment

Experimental group

Description:

Pembrolizumab + BrECADD

Treatment:

Drug: Pembrolizumab