Hodgkin Lymphoma
Conditions
Keywords
Hodgkin lymphoma, Prolgolimab, PD-1 inhibitors, Bendamustine, Immunotherapy, Relapsed/refractory, Autologous stem cell transplantation,
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.
Interventions
DRUGProlgolimab
Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles
DRUGCombination 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;
Sponsors
N.N. Petrov National Medical Research Center of Oncology
St. Petersburg State Pavlov Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate during prolgolimab monotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine) | 24 months | 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) | 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 |
| Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy | 12 months | Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0) |
| 1-year and 2-year progression-free survival | 24 months | Progression-free survival defined as the time from the protocol therapy initiation to disease progression, relapse or death from any reason. |
| Duration of response | 24 months | Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason |
| 1-year and 2-year overall survival | 24 months | Overall survival defined as the time from the protocol therapy initiation to death from any reason |
Countries
Russia
Contacts
Primary ContactKirill Lepik, MD, PhD
Backup ContactLiudmila Fedorova, MD
Outcome results
None listed