RecruitingPhase 2NCT06812858

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

Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

83 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Hodgkin Lymphoma

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether PD-1 inhibitors (a type of immunotherapy) used as maintenance therapy after a stem cell transplant can prevent relapse in people with high-risk classical Hodgkin lymphoma (cHL) — a cancer of the lymph nodes. **You may be eligible if...** - You are between 18 and 70 years old - You have relapsed or refractory Hodgkin lymphoma and received an autologous stem cell transplant (using your own stem cells) as consolidation therapy - Your lymphoma is considered high-risk (relapsed early, didn't respond to first treatment, or had other high-risk features) - You achieved a complete or partial response (visible improvement) on PET scan after the transplant - Your blood counts have recovered adequately after transplant **You may NOT be eligible if...** - You had severe (grade 3-4) side effects from the transplant - Your blood counts have not recovered sufficiently - Your general health is too poor (ECOG above 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab, Pembrolizumab

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(4)

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

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NCT06812858