Clinical trial · Interventional
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -
NCT02191930CI-TRIAL-00080130BVBcompletedPhase 2ClinicalTrials.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 trial is to determine 1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy 2. Progression-free survival (PFS) 3 years after registration
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B-CAP | Drug | — | UNRESOLVED |
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B-CAP
- description
- Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days
- interventionNames
- Drug: B-CAP
- type
- EXPERIMENTAL
- label
- Brentoximab Vedotin only
- description
- Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days
- interventionNames
- Drug: Brentuximab Vedotin
Primary outcomes (1)
- measure
- Objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria (B-CAP): * classical Hodgkin Lymphoma * Age 60 years or older * ECOG performance status ≤ 2 or ≤ 3 if due to HL * CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat) * Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease * written informed consent Exclusion Criteria (B-CAP): * Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) * Prior chemotherapy or radiation for HL except prephase * Peripheral neuropathy greater than CTC Grade 1 Inclusion Criteria (BV only): * classical Hodgkin Lymphoma * Age 60 years or older * stage IA to IVB * CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat) * Patients not eligible to curative poly-chemotherapy at the investigators judgment * written informed consent Exclusion Criteria (BV only): * Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) * Prior chemotherapy or radiation for HL except prephase as outlined in the protocol * Peripheral neuropathy greater than CTC Grade 1
References
Publications (0)
Data not yet available
No reference posted for this study.