Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

ConditionHodgkin Lymphoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-60

SponsorUniversity of Cologne

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-60

advanced stage classical Hodgkin Lymphoma

no previous treatment for cHL

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

Pembrolizumab
Drug
As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and BrECADD (P-BrECADD). Response to induction therapy will be measured after 1x P (PET-1) and after 1x P + 2x P-BrECADD (PET-3). Further systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two further cycles of P-BrECADD while participants with a positive PET-3 will receive four further cycles of P-BrECADD. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

progression free survival

Time frame

1 year

Sponsors and contacts

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University of Cologne

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: