Clinical trial · Interventional
PD-1 Inhibitors Maintenance for cHL Post-autoHCT
A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory/Relapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
NCT06812858CI-TRIAL-00112253recruitingPhase 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)
This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab, Pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Inhibitors maintenance
- interventionNames
- Drug: Nivolumab, Pembrolizumab
Primary outcomes (1)
- measure
- Assess the efficacy of PD-1 inhibitors as maintenance therapy after autoHCT in patients with r/r cHL, as assessed by 24-month progression-free surviva
- timeFrame
- From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 24 months
Secondary outcomes (4)
- measure
- To determine the 12- and 18-month PFS in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.
- timeFrame
- From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 12 or 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-70 years; * Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines; * High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (\> 12 months) with unfavourable prognosis factors (extranodal lesion and/or bulky and/or B-symptoms) / More than one salvage regimen performed) * Complete or partial response by PET/CT after auto-HSCT * No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study; * Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\> 1 109/L, absolute neutrophil count\> 0.5 109/L, platelets \> 25 109/L); * ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI Exclusion Criteria: * Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy; * Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN; * Respiratory failure of more than 1 degree at the time of inclusion in the study; * Unstable haemodynamics at the time of inclusion in the study; * Acute bacterial, viral or fungal infection at the time of inclusion; * Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible); * Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period; * Somatic or psychiatric pathology that prevents the signing of informed consent;
References
Publications (0)
Data not yet available
No reference posted for this study.