Back to resultsProlgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma (Prolgo-HL)
Primary Purpose
Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Prolgolimab
Combination with prolgolimab and bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Hodgkin lymphoma, Prolgolimab, PD-1 inhibitors, Bendamustine, Immunotherapy, Relapsed/refractory, Autologous stem cell transplantation,
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
Sites / Locations
- St. Petersburg State Pavlov Medical UniversityRecruiting
- N.N. Petrov National Medical Research Center of OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
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
1-year and 2-year overall survival
Overall survival defined as the time from the protocol therapy initiation to death from any reason
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.
Duration of response
Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason
Full Information
NCT ID
NCT05757466
First Posted
February 17, 2023
Last Updated
March 3, 2023
Sponsor
St. Petersburg State Pavlov Medical University
Collaborators
N.N. Petrov National Medical Research Center of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT05757466
Brief Title
Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma
Acronym
Prolgo-HL
Official Title
Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Anticipated)
Primary Completion Date
March 10, 2024 (Anticipated)
Study Completion Date
March 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University
Collaborators
N.N. Petrov National Medical Research Center of Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Hodgkin lymphoma, Prolgolimab, PD-1 inhibitors, Bendamustine, Immunotherapy, Relapsed/refractory, Autologous stem cell transplantation,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prolgolimab
Intervention Description
Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles
Intervention Type
Drug
Intervention Name(s)
Combination with prolgolimab and bendamustine
Intervention Description
Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles;
Primary Outcome Measure Information:
Title
Overall response rate during prolgolimab monotherapy
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy
Description
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
Time Frame
12 months
Title
Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)
Description
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
Time Frame
24 months
Title
Overall response rate during combination therapy (prolgolimab+bendamustine)
Description
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
Time Frame
24 months
Title
1-year and 2-year overall survival
Description
Overall survival defined as the time from the protocol therapy initiation to death from any reason
Time Frame
24 months
Title
1-year and 2-year progression-free survival
Description
Progression-free survival defined as the time from the protocol therapy initiation to disease progression, relapse or death from any reason.
Time Frame
24 months
Title
Duration of response
Description
Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirill Lepik, MD, PhD
Phone
+78123386265
Email
lepikkv@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liudmila Fedorova, MD
Phone
+78123386265
Email
md.FedorovaL@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirill Lepik, MD, PhD
Organizational Affiliation
St. Petersburg State Pavlov Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalia Mikhailova, MD
Organizational Affiliation
St. Petersburg State Pavlov Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
St. Petersburg State Pavlov Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirill Lepik, MD, PhD
Email
lepikkv@gmail.com
First Name & Middle Initial & Last Name & Degree
Liudmila Fedorova, MD, PhD
Email
md.FedorovaL@gmail.com
Facility Name
N.N. Petrov National Medical Research Center of Oncology
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilya Zyuzgin
Email
ilya.zyuzgin@gmail.com
First Name & Middle Initial & Last Name & Degree
Stanislav Volchenkov
Email
Stanislav.volchenkov@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma
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