Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma (Prolgo-HL)

December 16, 2023 updated by: Ivan S Moiseev, St. Petersburg State Pavlov Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Prolgolimab
Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate during prolgolimab monotherapy
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy
Time Frame: 12 months
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
12 months
Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)
Time Frame: 24 months
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
24 months
Overall response rate during combination therapy (prolgolimab+bendamustine)
Time Frame: 24 months
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
1-year and 2-year overall survival
Time Frame: 24 months
Overall survival defined as the time from the protocol therapy initiation to death from any reason
24 months
1-year and 2-year progression-free survival
Time Frame: 24 months
Progression-free survival defined as the time from the protocol therapy initiation to disease progression, relapse or death from any reason.
24 months
Duration of response
Time Frame: 24 months
Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Collaborators

N.N. Petrov National Medical Research Center of Oncology

Investigators

  • Principal Investigator: Kirill Lepik, MD, PhD, St. Petersburg State Pavlov Medical University
  • Study Chair: Natalia Mikhailova, MD, St. Petersburg State Pavlov Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Estimated)

March 10, 2024

Study Completion (Estimated)

March 10, 2025

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27/22-н

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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