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PD-1 Inhibitors Maintenance for cHL Post-autoHCT

RecruitingPhase 2Ages 18 Years - 70 YearsAllSt. Petersburg State Pavlov Medical University
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Nivolumab, Pembrolizumab
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Where

4 sites
National Research Oncology Center
Astana, Kazakhstan
National Medical and Surgical Center named after N.I. Pirogov
Moscow, Russia
RecruitingP. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
Moscow, Russia
RM Gorbacheva Research Institute, Pavlov University
Saint Petersburg, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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