No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
83 (estimated)
Sponsor
St. Petersburg State Pavlov Medical University · Other
Who this trial is looking for
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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)
Trial Locations
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Eligibility Criteria
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…
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;
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