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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03200977

Collaborator

(none)

Enrollment

Locations

78.5

Anticipated Duration (Months)

47.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Other: Non-Interventional

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

95 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Actual Study Start Date :

Jun 14, 2016

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Incidence of disease progression [Up to 2 years]
Measured by clinical assessment
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
Incidence of chronic Graft Versus Host Disease (GVHD) [Up to 2 years]
Measured by clinical assessment
Incidence of post-transplant sinusoidal obstruction syndrome (SOS) [Up to 2 years]
Measured by clinical assessment
Incidence of post-transplant interstitial pneumonitis (IPN) [Up to 2 years]
Measured by clinical assessment
Incidence of post-transplant renal toxicity requiring dialysis [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.
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.
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bristol-Myers Squibb	Princeton	New Jersey	United States	08540
2	Center for International Blood and Marrow Transplant Research	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT03200977

Other Study ID Numbers:

CA209-835

First Posted:

Jun 27, 2017

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Study Results

No Results Posted as of Mar 29, 2022