Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma

ConditionClassical Hodgkin Lymphoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Cologne

About this trial

The aim of the trial is to establish an individualized first-line treatment incorporating checkpoint inhibition for early-stage unfavorable cHL, which is effective and well tolerated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 for the main trial cohort

Age ≥ 61 years and eligible for AVD as determined by CIRS-G score and investigator for the exploratory cohort

First diagnosis of treatment-naïve cHL

large mediastinal mass

Disqualifiers

Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma

Trial design

Design model

Single group

Treatments tested in this trial

Tislelizumab
Drug
age 18-60: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT if PET positive resudues after the end of Tis or Tis-AVD age 60+: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT for all patients

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Arm A age 18-60Experimental treatment 1 intervention

Group B: Arm B Age 60+Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Progression Free Survival

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cologne

Lead sponsor

Source ClinicalTrials.gov

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