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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500571-32-00
Acronym
Uni-Koeln-4470
Enrollment
120
Registered
2023-12-18
Start date
2024-05-15
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Stage Unfavorable Classical Hodgkin Lymphoma

Brief summary

1-year progression-free survival (PFS) estimate

Detailed description

Adverse events, 3-year PFS estimate, 1- and 3-year overall survival (OS) estimates, Patient-reported outcomes (PRO-CTCAE, quality of life), Remission status after 2 doses of tislelizumab as determined by PET-2 (DS) and MTV-2, respectively, Remission status after completion of (chemo-) immunotherapy as determined by PET-6 (DS) and MTV-6, respectively, Remission status after end of treatment, Types of treatment applied in addition to trial treatment

Interventions

DRUGVINBLASTINE
DRUGDOXORUBICIN
DRUGDACARBAZINE
DRUGTislelizumab

Sponsors

University Of Cologne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1-year progression-free survival (PFS) estimate—

Secondary

MeasureTime frame
Adverse events, 3-year PFS estimate, 1- and 3-year overall survival (OS) estimates, Patient-reported outcomes (PRO-CTCAE, quality of life), Remission status after 2 doses of tislelizumab as determined by PET-2 (DS) and MTV-2, respectively, Remission status after completion of (chemo-) immunotherapy as determined by PET-6 (DS) and MTV-6, respectively, Remission status after end of treatment, Types of treatment applied in addition to trial treatment—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026