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An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.
This study will include a retrospective and prospective observational database analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed to nivolumab prior to allogeneic HCT | patients who were treated with nivolumab-based regimen prior to an allogeneic HCT |
| |
| Unexposed to nivolumab prior to allogeneic HCT | patients who were not treated with nivolumab-based regimen prior to an allogeneic HCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Related Mortality (TRM) | Treatment-Related Mortality at 6 months after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab | At 6 months after an allogeneic HCT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of disease progression | Measured by clinical assessment | Up to 2 years |
| Incidence of acute Graft Versus Host Disease (GVHD) | Either Grade II-IV or Grade III-IV acute GVHD. Measured by clinical assessment |
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Inclusion Criteria:
Exclusion Criteria:
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The study will target enrollment of 90 patients who were treated with nivolumab-based regimen prior to an allogeneic HCT with at least 45 patients who received nivolumab immediately prior to the allogeneic HCT
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Lawrenceville | New Jersey | 08543 | United States | ||
| Center for International Blood and Marrow Transplant Research |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| Up to 2 years |
| Incidence of chronic Graft Versus Host Disease (GVHD) | Measured by clinical assessment | Up to 2 years |
| Incidence of post-transplant sinusoidal obstruction syndrome (SOS) | Measured by clinical assessment | Up to 2 years |
| Incidence of post-transplant interstitial pneumonitis (IPN) | Measured by clinical assessment | Up to 2 years |
| Incidence of post-transplant renal toxicity requiring dialysis | Measured by clinical assessment | Up to 2 years |
| Overall Survival (OS) | OS is measured from the date of allogeneic transplant to death. | Up to 2 years |
| Progression-Free Survival (PFS) | PFS is measured from the date of allogeneic transplant to the date of disease progression or death. | Up to 2 years |
| TRM at 100 days | Treatment-Related Mortality at 100 days after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab | At 100 days after an allogeneic HCT |
| TRM at 1 year | Treatment-Related Mortality at 1 year after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab | At 1 year after an allogeneic HCT |
| TRM at 2 years | Treatment-Related Mortality at 2 years after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab | At 2 years after an allogeneic HCT |
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |