Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab
- Conditions
- Lymphoma
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT03200977
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 95
- 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.
- Patients with nodular lymphocyte-predominant HL
- Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed to nivolumab prior to allogeneic HCT Non-Interventional patients who were treated with nivolumab-based regimen prior to an allogeneic HCT Unexposed to nivolumab prior to allogeneic HCT Non-Interventional patients who were not treated with nivolumab-based regimen prior to an allogeneic HCT
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of post-transplant renal toxicity requiring dialysis Up to 2 years Measured by clinical assessment
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
Incidence of disease progression Up to 2 years Measured by clinical assessment
Incidence of chronic Graft Versus Host Disease (GVHD) Up to 2 years Measured by clinical assessment
Incidence of post-transplant interstitial pneumonitis (IPN) Up to 2 years Measured by clinical assessment
Overall Survival (OS) Up to 2 years OS is measured from the date of allogeneic transplant to 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
Incidence of post-transplant sinusoidal obstruction syndrome (SOS) Up to 2 years Measured by clinical assessment
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
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
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.
Trial Locations
- Locations (2)
Bristol-Myers Squibb
🇺🇸Princeton, New Jersey, United States
Center for International Blood and Marrow Transplant Research
🇺🇸Milwaukee, Wisconsin, United States