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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03200977
• Other study ID #: CA209-835
• Status: Active, not recruiting
• Start date: June 14, 2016
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: December 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Center for International Blood and Marrow Transplant Research	Milwaukee	Wisconsin
United States	Bristol-Myers Squibb	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of disease progression	Measured by clinical assessment	Up to 2 years
Secondary	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
Secondary	Incidence of chronic Graft Versus Host Disease (GVHD)	Measured by clinical assessment	Up to 2 years
Secondary	Incidence of post-transplant sinusoidal obstruction syndrome (SOS)	Measured by clinical assessment	Up to 2 years
Secondary	Incidence of post-transplant interstitial pneumonitis (IPN)	Measured by clinical assessment	Up to 2 years
Secondary	Incidence of post-transplant renal toxicity requiring dialysis	Measured by clinical assessment	Up to 2 years
Secondary	Overall Survival (OS)	OS is measured from the date of allogeneic transplant to death.	Up to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form