Relapsed or Refractory Hodgkin's Lymphoma Clinical Trial
Official title:
Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin: a Multicenter, Prospective, Observational Study in a Real World Setting
The goal of this is study is focusing on assessment of patient-reported outcomes in terms of quality of life (QoL) and symptom profile as well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.
Information on QoL in patients with refractory/relapsed HL treated with BV is quite limited
till now. Moreover, PRO data in patients treated for refractory/relapsed HL with BV,
including long-term effects of BV on patient's QoL in a real-world setting are lacking.
The goal of this is study is focusing on assessment of patient-reported outcomes in terms of
QoL and symptom profileas well on evaluation of clinical efficacy and safety of BV in
patients with refractory/resistant HL in a real-world setting.
For PROs assessment QoL and symptom data will be received from patients' reports before and
at 3, 6, 9, 12 months after BV treatment start and in 3 months at follow-up (15 months after
base-line). The maximum duration of PRO monitoring - 15 months. To evaluate PROs the
followings tools will be used: RAND SF-36 for quality of life assessment, Edmonton Symptom
Assessment System (ESAS-R) for symptom assessment and Patient Global Impression of Change
(PGIC) for assessment of a patient's belief about the effect of treatment.
For evaluation of response rates, duration of response, PFS and for analysis of AEs/SAEs
during BV treatment the clinical data will be collected from health records at base-line, at
3, 6, 9, 12 months after BV treatment start and at 15 months of follow-up or till the last
dose of BV.
No randomization and stratification will be applied. The analysis of primary (PROs
assessment) and secondary outcomes (clinical outcomes) will be provided in the total patient
population (n=70) and in two subgroups. The subgroups of interest will be: patients with
relapsed or refractory HL who are not candidates for ASCT with prescribed treatment with BV
as ≥2nd line therapy, and patients with relapse after ASCT with prescribed treatment with BV.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05300282 -
Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
|
Phase 1/Phase 2 |