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

NCT ID: NCT05757466

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2025-03-10

Brief 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.

Conditions

Hodgkin Lymphoma

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Main arm

Patients receive 6 cycles of prolgolimab monotherapy with subsequent assessment of response by PET/CT using Lugano and LYRIC criteria. Patients with complete response continue prolgolimab therapy for up to 24 cycles. Patients are switched to combination therapy with prolgolimab and chemotherapy (bendamustine) if the complete response is not achieved after 6 cycles of therapy or in case of relapse during prolgolimab monotherapy.

Patients without complete response after 6 cycles of prolgolimab monotherapy or with relapse during monotherapy will receive 3 cycles of combination therapy with prolgolimab and bendamustine every 28 days. Collection of hematopoietic stem cells is performed at any stage of combination therapy. Response evaluation after 3 cycles of combination therapy is performed by PET/CT using Lugano and LYRIC criteria. Autologous stem cell transplantation is conducted in patients who achieve complete or partial response.

Group Type: EXPERIMENTAL

Prolgolimab

Intervention Type: DRUG

Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles

Combination with prolgolimab and bendamustine

Intervention Type: DRUG

Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles;

Interventions

Prolgolimab

Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles

Intervention Type: DRUG

Combination with prolgolimab and bendamustine

Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles;

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

N.N. Petrov National Medical Research Center of Oncology

OTHER

Sponsor Role: collaborator

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

Vice-director for science RM Gorbacheva Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirill Lepik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Petersburg State Pavlov Medical University

Natalia Mikhailova, MD

Role: STUDY_CHAIR

St. Petersburg State Pavlov Medical University

Locations

St. Petersburg State Pavlov Medical University

Saint Petersburg, , Russia

Site Status: RECRUITING

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Kirill Lepik, MD, PhD

Role: CONTACT

Phone: +78123386265

Email: lepikkv@gmail.com

Liudmila Fedorova, MD

Role: CONTACT

Phone: +78123386265

Email: md.FedorovaL@gmail.com

Facility Contacts

Kirill Lepik, MD, PhD

Role: primary

Liudmila Fedorova, MD, PhD

Role: backup

Ilya Zyuzgin

Role: primary

Stanislav Volchenkov

Role: backup

Other Identifiers

27/22-н

Identifier Type: -

Identifier Source: org_study_id