Clinical trial · Observational
B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes
An International, Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With Classical Hodgkin Lymphoma (B-HOLISTIC)
NCT03327571CI-TRIAL-00052449B-HOLISTICcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
| Relapsed or Refractory Classical Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group 1: cHL
- description
- Participants diagnosed with high-risk stage IIb-IV cHL, received frontline treatment with chemotherapy with or without radiotherapy between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for cHL, associated adverse events and resources used from the date of cHL diagnosis until the date of first documented relapse or disease progression after frontline therapy. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
- label
- Group 2: RRHL
- description
- Participants diagnosed with RRHL, between 01 January 2010 and 31 December 2013 from the 13 participating countries will be observed for various treatments received for RRHL, detailed data on treatment pathways, clinical outcomes, associated adverse events and resources used from the date of RRHL diagnosis until the date death or data collection, whichever occurs first. Participants will be continue to be observed for overall survival until the date of death or data collection, whichever occurs first.
Primary outcomes (1)
- measure
- Group 2, RRHL: Progression Free Survival (PFS)
- timeFrame
- From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013. 2. Age greater than or equal to (\>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2). 3. Alive or deceased. 4. Written informed consent is obtained for study data collection, where necessary, according to local regulations. Exclusion Criteria: 1. Participants for whom the minimum study dataset is not available from their hospital medical records. 2. Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.
References
Publications (2)
- DERIVEDHernandez-Caballero A, Salazar R, Zerga M, Rivas-Vera S, Huang Z, Karduss A. Subgroup analysis of treatment pathways and clinical outcomes in Hodgkin lymphoma in Latin America from the retrospective B-HOLISTIC study. Sci Rep. 2025 Jul 7;15(1):24197. doi: 10.1038/s41598-025-07704-0. PMID 40624058
- DERIVEDFerhanoglu B, Kim TM, Karduss A, Brittain D, Tumyan G, Al-Mansour M, Zerga M, Song Y, Rivas-Vera S, Kwong YL, Lim ST, Yeh SP, Abdillah A, Huang Z, Dalal M, Wan H, Hertzberg M. Treatment pathways and clinical outcomes in Hodgkin lymphoma outside Europe and North America: results from the international, multicenter, retrospective, B-HOLISTIC study. Leuk Lymphoma. 2022 Dec;63(14):3317-3330. doi: 10.1080/10428194.2022.2126281. Epub 2022 Oct 6. PMID 36200380