Refractory / relapsed Hodgkin's lymphoma
Conditions
Brief summary
Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N)., PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause.
Detailed description
Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment., Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause., Percentage of patients among whom aHCT was successfully performed., Tolerance of N-BGD treatment defined as the frequency of adverse events (AEs) with a toxicity level greater than two based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.
Interventions
DRUGNIVOLUMAB
Sponsors
Medical University Of Gdansk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N)., PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment., Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause., Percentage of patients among whom aHCT was successfully performed., Tolerance of N-BGD treatment defined as the frequency of adverse events (AEs) with a toxicity level greater than two based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5. | — |
Countries
Poland
Outcome results
None listed