NCT03200977CompletedNot Applicable
Observational Cohort Study to Characterize the Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab
Bristol-Myers Squibb2 sites in 1 country95 target enrollmentStarted: July 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 95
- Locations
- 2
- Primary Endpoint
- Treatment-Related Mortality (TRM)
Study Overview
Brief Summary
An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.
Detailed Description
This study will include a retrospective and prospective observational database analysis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Incidence of post-transplant renal toxicity requiring dialysis(Up to 2 years)
- TRM at 2 years(At 2 years after an allogeneic HCT)
- Incidence of disease progression(Up to 2 years)
- Incidence of chronic Graft Versus Host Disease (GVHD)(Up to 2 years)
- Incidence of post-transplant interstitial pneumonitis (IPN)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- TRM at 100 days(At 100 days after an allogeneic HCT)
- Incidence of post-transplant sinusoidal obstruction syndrome (SOS)(Up to 2 years)
- TRM at 1 year(At 1 year after an allogeneic HCT)
- Incidence of acute Graft Versus Host Disease (GVHD)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
Investigators
Study Sites (2)
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