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Completed

NCT Number: NCT03200977

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001, Lawrenceville, New Jersey, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Treatment-Related Mortality (TRM)

    Time frame: 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 outcomes

  1. Incidence of disease progression

    Time frame: Up to 2 years

    Measured by clinical assessment

  2. Incidence of acute Graft Versus Host Disease (GVHD)

    Time frame: Up to 2 years

    Either Grade II-IV or Grade III-IV acute GVHD. Measured by clinical assessment

  3. Incidence of chronic Graft Versus Host Disease (GVHD)

    Time frame: Up to 2 years

    Measured by clinical assessment

  4. Incidence of post-transplant sinusoidal obstruction syndrome (SOS)

    Time frame: Up to 2 years

    Measured by clinical assessment

  5. Incidence of post-transplant interstitial pneumonitis (IPN)

    Time frame: Up to 2 years

    Measured by clinical assessment

  6. Incidence of post-transplant renal toxicity requiring dialysis

    Time frame: Up to 2 years

    Measured by clinical assessment

  7. Overall Survival (OS)

    Time frame: Up to 2 years

    OS is measured from the date of allogeneic transplant to death.

  8. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

    PFS is measured from the date of allogeneic transplant to the date of disease progression or death.

  9. TRM at 100 days

    Time frame: 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

  10. TRM at 1 year

    Time frame: 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

  11. TRM at 2 years

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2017
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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