PD-1 Inhibitors Maintenance for cHL Post-autoHCT

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT06812858
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab, Pembrolizumab — DRUG
    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

Study Details

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)

Key Dates

Start date
Jan 9, 2024
Status verified
May 2025
Primary completion
May 31, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
83 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD-1 Inhibitors maintenance

Primary Outcome 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 [ 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 months ]

Central Contacts

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