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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d, stage IIB with risk factors c-d): 1. large mediastinal mass 2. extranodal lesion(s) 3. elevated erythrocyte sedimentation rate 4. ≥ 3 nodal areas Who Should NOT Join This Trial: - Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 * Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d, stage IIB with risk factors c-d): 1. large mediastinal mass 2. extranodal lesion(s) 3. elevated erythrocyte sedimentation rate 4. ≥ 3 nodal areas Exclusion Criteria: * Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma

Treatments Being Tested

DRUG

Tislelizumab

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

Locations (1)

1st Department of Medicine, Cologne University Hospital
Cologne, Germany