Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
Who is this study for? Patients with Classical Hodgkin Lymphoma
What treatments are being studied? Tislelizumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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):
‣ large mediastinal mass
⁃ extranodal lesion(s)
⁃ elevated erythrocyte sedimentation rate
⁃ ≥ 3 nodal areas
Locations
Other Locations
Germany
1st Department of Medicine, Cologne University Hospital
RECRUITING
Cologne
Contact Information
Primary
Michael Fuchs
ghsg@uk-koeln.de
+49221478
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2028-05
Participants
Target number of participants: 120
Treatments
Experimental: Arm A age 18-60
Patients at the age of 18-60 years at enrollment will receive 2 initial doses of 200 mg tislelizumab in 21-day intervals followed by an interim positron emission tomography (PET-2). Following a PET-guided approach, patients with a negative PET-2 (i.e. Deauville score 1-3) according to central review will continue receiving tislelizumab for another 4 doses of 300 mg in 28-day intervals. Patients with a positive PET-2 (i.e. Deauville score \>3) will receive 4 cycles of combined 300 mg tislelizumab on day 1 and AVD chemotherapy on day 1 and 15 in 28-day cycles (4x T-AVD). For all patients, 30 Gy involved-site radiotherapy (IS-RT) will only be applied in case of PET positivity after completion of (chemo-) immunotherapy.
Experimental: Arm B Age 60+
Patients above the age of 60 years will be enrolled in a separate, exploratory cohort and receive PET-guided treatment with tislelizumab or T-AVD as described above. However, all patients in the exploratory cohort for older patients will receive consolidating 30 Gy IS-RT.
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Cologne