Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma

NCT ID: NCT04838652

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2028-05-31

Brief Summary

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).

Conditions

Classical Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab plus Chemotherapy

All patients will receive 1 dose of 200 mg pembrolizumab IV as single agent upfront, followed by 2 cycles of IV P-ICE (pembrolizumab, ifosfamide, carboplatin, etoposide) and a PET/CT-based restaging. Following a PET-guided treatment strategy, patients will then receive either another 2 cycles of IV P-ICE in case of a negative PET (i.e., Deauville score 1-3), or 2 to 4 cycles of IV P-DHAP (pembrolizumab, dexamethasone, cytarabine, cisplatin) in case of a positive PET (i.e., Deauville score \> 3). After completion of treatment with P-ICE or P-DHAP, respectively, patients will receive a consolidation therapy with pembrolizumab for another 6 cycles. In case of non-CR after at least 4 cycles of combination therapy (4x P-ICE or 2x P-ICE + 2x P-DHAP), physicians may decide to go for HDCT or an alternative standard of care treatment option.

Group Type: EXPERIMENTAL

Pembrolizumab plus Chemotherapy (ICE or DHAP)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion Criteria

• Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Peter Borchmann

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Engert, Prof.

Role: PRINCIPAL_INVESTIGATOR

1st Department of Medicine, Cologne Universit Hospital

Locations

1st Department of Medicine, Cologne University Hospital

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Fuchs

Role: CONTACT

ghsg@uk-koeln.de

+49221478 ext. 88160

Facility Contacts

Michael Fuchs

Role: primary

GHSG@uk-koeln.de

+49221478 ext. 88160

Other Identifiers

Uni-Koeln-3942

Identifier Type: -

Identifier Source: org_study_id