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Trial Title:
Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma
NCT ID:
NCT05757466
Condition:
Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Bendamustine Hydrochloride
Conditions: Keywords:
Hodgkin lymphoma
Prolgolimab
PD-1 inhibitors
Bendamustine
Immunotherapy
Relapsed/refractory
Autologous stem cell transplantation,
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Prolgolimab
Description:
Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles
Arm group label:
Main arm
Intervention type:
Drug
Intervention name:
Combination with prolgolimab and bendamustine
Description:
Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3
cycles;
Arm group label:
Main arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Petersburg State Pavlov Medical University
Address:
City:
Saint Petersburg
Zip:
197022
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Kirill Lepik, MD, PhD
Email:
lepikkv@gmail.com
Contact backup:
Last name:
Liudmila Fedorova, MD, PhD
Email:
md.FedorovaL@gmail.com
Facility:
Name:
N.N. Petrov National Medical Research Center of Oncology
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ilya Zyuzgin
Email:
ilya.zyuzgin@gmail.com
Contact backup:
Last name:
Stanislav Volchenkov
Email:
Stanislav.volchenkov@yahoo.com
Start date:
April 19, 2023
Completion date:
March 10, 2025
Lead sponsor:
Agency:
St. Petersburg State Pavlov Medical University
Agency class:
Other
Collaborator:
Agency:
N.N. Petrov National Medical Research Center of Oncology
Agency class:
Other
Source:
St. Petersburg State Pavlov Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05757466
