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

Hodgkin Lymphoma Clinical Trial

— Prolgo-HL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757466
• Other study ID #: 27/22-?
• Status: Recruiting
• Phase: Phase 2
• Start date: April 19, 2023
• Est. completion date: March 10, 2025

Study information

• Verified date: December 2023
• Source: St. Petersburg State Pavlov Medical University
• Contact: Kirill Lepik, MD, PhD
• Phone: +78123386265
• Email: lepikkv[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 10, 2025
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Russian Federation	N.N. Petrov National Medical Research Center of Oncology	Saint Petersburg
Russian Federation	St. Petersburg State Pavlov Medical University	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University	N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate during prolgolimab monotherapy	Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria	12 months
Secondary	Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy	Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)	12 months
Secondary	Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)	Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)	24 months
Secondary	Overall response rate during combination therapy (prolgolimab+bendamustine)	Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria	24 months
Secondary	1-year and 2-year overall survival	Overall survival defined as the time from the protocol therapy initiation to death from any reason	24 months
Secondary	1-year and 2-year progression-free survival	Progression-free survival defined as the time from the protocol therapy initiation to disease progression, relapse or death from any reason.	24 months
Secondary	Duration of response	Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason	24 months