Clinical trial · Interventional
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
NCT03652441CI-TRIAL-00104794completedPhase 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 aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year. The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
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 |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maintenance
- description
- Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
- interventionNames
- Drug: Brentuximab Vedotin
Primary outcomes (1)
- measure
- 1-year Cumulative incidence of relapse (CIR)
- timeFrame
- 1 year
- description
- 1-year Cumulative incidence of relapse (CIR)
Secondary outcomes (1)
- measure
- 1- and 2-year Progression-free survival (PFS)
- timeFrame
- 1 and 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation * Histologically proven cHL in the most recent tumor biopsy * Absolute neutrophil count ≥ 500/mm³ * ECOG ≤2 * Age ≥ 18 years Exclusion Criteria: * Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma * Progressive disease as last documented response prior to alloSCT * Any peripheral neuropathy ≥ grade 2 * Any other serious disease or organ dysfunction which might impair protocol treatment
References
Publications (0)
Data not yet available
No reference posted for this study.