Prolgolimab treatment for relapsed or refractory Hodgkin lymphoma

Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma

This study is testing if a new treatment called prolgolimab, alone or with another drug, can help people with relapsed or hard-to-treat Hodgkin lymphoma feel better and stay in remission longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: St. Petersburg State Pavlov Medical University (Academic / other)
• Drugs / interventions: Prolgolimab, immunotherapy
• Locations: 2 sites (Saint Petersburg and 1 other locations)
• Trial ID: NCT05757466 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of prolgolimab, an anti-PD-1 inhibitor, either alone or in combination with bendamustine for patients with relapsed or refractory classical Hodgkin lymphoma. The study aims to evaluate the safety and efficacy of this treatment approach, which has shown promise in achieving long-term remission in heavily pretreated patients. By utilizing a PET-adapted therapy strategy, the trial seeks to improve patient outcomes while potentially avoiding the need for autologous stem cell transplantation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with a histologically verified diagnosis of classical Hodgkin lymphoma who have relapsed or are refractory after first-line therapy.

Not a fit: Patients with severe organ failure, uncontrolled infections, or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to prolonged remission and improved survival rates for patients with relapsed or refractory classical Hodgkin lymphoma.

How similar studies have performed: Other studies have shown success with PD-1 inhibitors in similar contexts, indicating a promising avenue for treatment in Hodgkin lymphoma.

Eligibility criteria

Inclusion Criteria:

* Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
* Age 18-70 y
* Ejection fraction not less than 50%
* No severe concurrent illness
* 0-2 ECOG status
* Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug.

Exclusion Criteria:

* Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms;
* Respiratory failure \> grade 1 at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Active or prior documented autoimmune disease requiring systemic treatment
* Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
* Hypersensitivity or allergy to study drugs
* Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
* Simultaneous use of drugs or medical devices studied in other clinical trials
* Use of PD-1 inhibitors or bendamustine in the 1st line of therapy

Where this trial is running

Saint Petersburg and 1 other locations

• St. Petersburg State Pavlov Medical University — Saint Petersburg, Russian Federation (Recruiting)
• N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg, Russian Federation (Recruiting)

Study contacts

• Principal investigator: Kirill Lepik, MD, PhD — St. Petersburg State Pavlov Medical University
• Study coordinator: Kirill Lepik, MD, PhD

Conditions Hodgkin Lymphoma; Hodgkin lymphoma; Prolgolimab; PD-1 inhibitors; Bendamustine; Immunotherapy; Relapsed/refractory; Autologous stem cell transplantation,