Clinical trial NCT03200977: Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment-Related Mortality (TRM)
timeFrame: At 6 months after an allogeneic HCT
Secondary outcomes:
measure: Incidence of disease progression
timeFrame: Up to 2 years
measure: Incidence of acute Graft Versus Host Disease (GVHD)
timeFrame: Up to 2 years
measure: Incidence of chronic Graft Versus Host Disease (GVHD)
timeFrame: Up to 2 years
measure: Incidence of post-transplant sinusoidal obstruction syndrome (SOS)
timeFrame: Up to 2 years
measure: Incidence of post-transplant interstitial pneumonitis (IPN)
timeFrame: Up to 2 years
measure: Incidence of post-transplant renal toxicity requiring dialysis
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: TRM at 100 days
timeFrame: At 100 days after an allogeneic HCT
measure: TRM at 1 year
timeFrame: At 1 year after an allogeneic HCT
measure: TRM at 2 years
timeFrame: At 2 years after an allogeneic HCT
Other outcomes:
Locations:
city: Lawrenceville
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Milwaukee
country: United States
facility: Center for International Blood and Marrow Transplant Research
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: