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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Other: Non-Interventional

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bristol-Myers Squibb
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Center for International Blood and Marrow Transplant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed to nivolumab prior to allogeneic HCT; patients who were treated with nivolumab-based regimen prior to an allogeneic HCT	Other: Non-Interventional; 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; Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: CA209-835