RECRUITINGPhase 2INTERVENTIONAL
Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
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