Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2025-03-10
• Target enrollment: 0
• Participant gender: All

Summary

Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).

The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Petersburg State Pavlov Medical University
• Collaborator: N.N. Petrov National Medical Research Center of Oncology
• Treatments: Bendamustine Hydrochloride

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