Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivo-AVD | Experimental | Nivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total) |
|
| BEACOPP-like regimes - Standard cohort | Active Comparator | In the Standard cohort, patients will receive therapy according to current clinical guidelines for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to an A(B)VD regimen (when achieving CR by PET/CT) or continuing therapy with BEACOPP-like regimens (when achieving PR,SD by PET/CT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivo-AVD | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | To compare the safety of therapy use in the Nivo-AVD and Standard cohorts: analysis of the incidence, severity and spectrum of adverse events (according to CTCAE v5.0 criteria) | Up to 24 months from thetreatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | To compare progression-free survival in the Nivo-AVD and Standard cohorts | 12, 24 and 36 months after completion of therapy |
| Response rates | To compare the rates of objective response, complete and partial responses after 2 and 6 courses of therapy in the Nivo-AVD and Standard cohorts by whole-body PET-CT (according to Lugano criteria for chemotherapy and LYRIC criteria for immunochemotherapy) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liudmila Fedorova, MD, PhD | Contact | +78123386265 | md.FedorovaL@gmail.com | |
| Polina Kotseliabina, MD | Contact | +78123386265 | polina.kotselyabina.med@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Natalia Mikhailova, MD, PhD | St. Petersburg State Pavlov Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health | Recruiting | Moscow | Russia |
Not provided
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BEACOPP-like | Drug |
|
|
| after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months) |
| Overall survival | - To compare overall survival at 12, 24, and 36 months after completion of therapy in the Nivo-AVD and Standard cohorts. | 12, 24, and 36 months after completion of therapy |
| National Medical and Surgical Center named after N.I. Pirogov | Recruiting | Moscow | Russia |
|
| St. Petersburg State Pavlov Medical University | Recruiting | Saint Petersburg | Russia |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |