A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma
ConditionHodgkin Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda
About this trial
The main aim is to check how effective BV is for treating adults with HL.
Study medication will be prescribed according to the clinic's standard practice.
Participants will visit the study clinic 5 times, once every 12 weeks. When study treatment has completed, a follow-up visit will be scheduled every 3 months during the first year and every 4-6 months during the next year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Currently participates or plans to participate in any interventional clinical trial.
Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Trial population
Participants diagnosed with HL (previously enrolled in BV HL NDP) who underwent or are candidates for ASCT will be enrolled in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionThis is a non-interventional study.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: HL Participants: BV Salvage Pre-ASCT1 intervention
Group B: HL Participants: BV Consolidation Treatment Post-ASCT1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS) as Assessed by Investigator
PFS will be assessed by investigator and defined as the time from the first dose of BV post ASCT until the first occurrence of disease progression or relapse, or death for any reason. Disease progression is at least a 50 percent (%) increase in the size of lesions, or the occurrence of new lesions. It will be analyzed using Kaplan-Meier method.
Time frame
From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)Secondary outcomes
1
Overall Survival (OS)
OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method.
Time frame
From initiation of BV treatment until death from any cause (up to 36 months) Source ClinicalTrials.gov