PD-1 Inhibitors Maintenance for cHL Post-autoHCT
ConditionHodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSt. Petersburg State Pavlov Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Nivolumab, Pembrolizumab
DrugThe 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
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: PD-1 Inhibitors maintenanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
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 monthsSecondary outcomes
1
To determine the 12- and 18-month PFS in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.
Time frame
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 months2
To determine the 12-, 18-, and 24-month overall survival (OS) in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.
Time frame
From the first dose of study treatment to death from any cause, assessed up to 12, 18 and 24 months3
To determine the 12-, 18-, and 24-month cumulative incidence of relapse (CIR) in patients with r/r cHL receiving PD-1 inhibitors as maintenance therapy following auto-HSCT.
Time frame
Up to 12, 18 and 24 months4
To establish the safety and tolerability of PD-1 inhibitors in the maintenance setting, defined as the frequency, severity, and spectrum of adverse events (AEs)
Incidence of toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5
Time frame
observed during therapy and for one year following completion of maintenance therapy.Sponsors and contacts
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Source ClinicalTrials.gov