Lymphoma
Conditions
Brief summary
An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.
Detailed description
This study will include a retrospective and prospective observational database analysis.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Related Mortality (TRM) | At 6 months after an allogeneic HCT | Treatment-Related Mortality at 6 months after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute Graft Versus Host Disease (GVHD) | Up to 2 years | Either Grade II-IV or Grade III-IV acute GVHD. Measured by clinical assessment |
| Incidence of chronic Graft Versus Host Disease (GVHD) | Up to 2 years | Measured by clinical assessment |
| Incidence of post-transplant sinusoidal obstruction syndrome (SOS) | Up to 2 years | Measured by clinical assessment |
| Incidence of post-transplant interstitial pneumonitis (IPN) | Up to 2 years | Measured by clinical assessment |
| Incidence of post-transplant renal toxicity requiring dialysis | Up to 2 years | Measured by clinical assessment |
| Incidence of disease progression | Up to 2 years | Measured by clinical assessment |
| Progression-Free Survival (PFS) | Up to 2 years | PFS is measured from the date of allogeneic transplant to the date of disease progression or death. |
| TRM at 100 days | At 100 days after an allogeneic HCT | Treatment-Related Mortality at 100 days after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab |
| TRM at 1 year | At 1 year after an allogeneic HCT | Treatment-Related Mortality at 1 year after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab |
| TRM at 2 years | At 2 years after an allogeneic HCT | Treatment-Related Mortality at 2 years after an allogeneic Hemaetopoietic Cell Transplantation (HCT) among patients with cHL who were previously treated with nivolumab |
| Overall Survival (OS) | Up to 2 years | OS is measured from the date of allogeneic transplant to death. |
Countries
United States
Outcome results
None listed