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

NCT ID: NCT03200977

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2022-06-03

Brief Summary

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

Detailed Description

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

Conditions

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Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Exposed to nivolumab prior to allogeneic HCT

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

Non-Interventional

Intervention Type OTHER

Non-Interventional

Unexposed to nivolumab prior to allogeneic HCT

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

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Lawrenceville, New Jersey, United States

Site Status

Center for International Blood and Marrow Transplant Research

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-835

Identifier Type: -

Identifier Source: org_study_id

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