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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Lymphoma

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03200977

CA209-835

Details and patient eligibility

About

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

Full description

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

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

95 participants in 2 patient groups

Exposed to nivolumab prior to allogeneic HCT

Description:

patients who were treated with nivolumab-based regimen prior to an allogeneic HCT

Treatment:

Other: Non-Interventional

Unexposed to nivolumab prior to allogeneic HCT

Description:

patients who were not treated with nivolumab-based regimen prior to an allogeneic HCT

Treatment:

Other: Non-Interventional