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

NCT03200977 | Completed

• 1 other identifier: CA209-835
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Incidence of disease progression

  Up to 2 years

• Incidence of acute Graft Versus Host Disease (GVHD)

  Up to 2 years

• Incidence of chronic Graft Versus Host Disease (GVHD)

  Up to 2 years

• Incidence of post-transplant sinusoidal obstruction syndrome (SOS)

  Up to 2 years

• Incidence of post-transplant interstitial pneumonitis (IPN)

  Up to 2 years

Study Arms (2)

Exposed to nivolumab prior to allogeneic HCT

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

Other: Non-Interventional

Unexposed to nivolumab prior to allogeneic HCT

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

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Exposed to nivolumab prior to allogeneic HCT; Unexposed to nivolumab prior to allogeneic HCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will target enrollment of 90 patients who were treated with nivolumab-based regimen prior to an allogeneic HCT with at least 45 patients who received nivolumab immediately prior to the allogeneic HCT

You may qualify if:

• 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.

You may not qualify if:

• Patients with nodular lymphocyte-predominant HL
• Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Lawrenceville, New Jersey, 08543, United States

Location

Center for International Blood and Marrow Transplant Research

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 27, 2017
• Study Start: July 1, 2016
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (2)