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
St. Petersburg State Pavlov Medical University
83 participants
Sep 2, 2024
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria7
- 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 Criteria8
- 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;
Interventions
The choice of drug and its dose for maintenance therapy is at the discretion of the study centre (e.g. nivolumab, pembrolizumab). Maintenance therapy should be initiated no later than 60 days after D0, exceptions may be made due to reasonable justification in consultation with the Study PI and will not be considered a protocol deviation. Nivolumab maintenance therapy regimens: * Nivolumab (40 mg, fixed dose) IV D1 of each 14-days cycle up to 12 cycles * Nivolumab (3 mg/kg) IV D1 of each 14-days cycle up to 12 cycles Pembrolizumab maintenance therapy regimen: -Pembrolizumab (200 mg, fixed dose) IV D1 of each 21-days cycle up to 8 cycles
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06812858