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| Name | Class |
|---|---|
| N.N. Petrov National Medical Research Center of Oncology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolgolimab | Drug | Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirill Lepik, MD, PhD | Contact | +78123386265 | lepikkv@gmail.com | |
| Liudmila Fedorova, MD | Contact | +78123386265 | md.FedorovaL@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kirill Lepik, MD, PhD | St. Petersburg State Pavlov Medical University | Principal Investigator |
| Natalia Mikhailova, MD | St. Petersburg State Pavlov Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Petersburg State Pavlov Medical University | Recruiting | Saint Petersburg | 197022 | Russia |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Combination with prolgolimab and bendamustine | Drug | Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles; |
|
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) | 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 | 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 | 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 | Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason | 24 months |
| N.N. Petrov National Medical Research Center of Oncology | Recruiting | Saint Petersburg | Russia |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |