Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab

Study Overview
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Brief Summary
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An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.

Detailed Description
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This study will include a retrospective and prospective observational database analysis.

Official Title
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Observational Cohort Study to Characterize the Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab

Conditions
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Lymphoma

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to18 years; First allogeneic HCT for cHL; Patients with prior autologous HCT for cHL; Any conditioning regimen, graft source or donor type. For the primary analysis additional criterion includes prior exposure to nivolumab for treatment of cHL immediately prior to the allogeneic HCT, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic HCT with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months. Exclusion Criteria: Patients with nodular lymphocyte-predominant HL Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed to nivolumab prior to allogeneic HCT<br>patients who were treated with nivolumab-based regimen prior to an allogeneic HCT | Other: Non-Interventional<br>* Non-Interventional<br>|
| Unexposed to nivolumab prior to allogeneic HCT<br>patients who were not treated with nivolumab-based regimen prior to an allogeneic HCT | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |