NCT03440788

Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Multinational Center for Quality of Life Research, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapsed or Refractory Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Brentuximab vedotin (BV) will be prescribed to patients in accordance with indication for treatment as second or subsequent line therapy after failure of at least one type of first-line therapy for patients with relapsed or refractory HL who are not candidates for ASCT, or for patients with relapse after ASCT within routine hematological practice. Dose, preparation, administration etc - as in Instruction for use (Prescribing information).

Timeline

• Start date: 2018-04-02
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-02-22
• Last updated: 2019-10-28

Locations

9 sites across 1 country: Russia