Clinical trial · Interventional
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment With or Without Bendamustine
NCT06931613CI-TRIAL-00088669enrolling by invitationPhase 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)
Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Haemopoietic Stem Cell Transplant | — | UNRESOLVED | — |
| Children | — | UNRESOLVED | — |
| Nivolumab | — | UNRESOLVED | — |
| Relapsed or Refractory Hodgkin Lymphoma | Hodgkin Lymphoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Event free survival
- timeFrame
- 5-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies * Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT). * Number of previous lines of therapy \>2 * Karnofsky index ≥60% * availability of signed informed consent - Exclusion Criteria: * Number of previous lines of therapy ≤ 2 * Karnofsky index \< 60 * Intolerance to drugs used in the study * Presence of a second tumor * Pregnancy or lactation * Participation in another study within six months * Presence of concomitant severe disease * Presence of HIV and/or viral hepatitis (B or C)
References
Publications (0)
Data not yet available
No reference posted for this study.