Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin
- Conditions
- Relapsed or Refractory Hodgkin's Lymphoma
- Registration Number
- NCT03440788
- Lead Sponsor
- Multinational Center for Quality of Life Research, Russia
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- Adult patients with confirmed diagnosis of relapsed or refractory HL
- At least 18 years of age at time of BV treatment decision
- 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
- Patients with given informed consent
- Patients who are capable to fill out questionnaires
- Patients with expected life duration of at least 6 months
- Patients enrolled in clinical trials
- Patients with contraindications to BV in accordance with instruction for use
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in QoL and symptom severity while treatment with BV At 3, 6, 9 and 12 months of BV treatment and at 15 months after treatment start The change in QoL will be assessed as the difference in QoL scales of RAND SF-36 as compared to their baseline and the difference in proportion of patients with significant negative impact on QoL. The change in symptom severity will be assessed as the difference in the severity of each ESAS-R scale and the symptom distress score as compared with their baseline value. The proportion of patients with ≥1 point improvement on ESAS-R scale will be analyzed as well.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 15 months PFS will be estimated from initiation of treatment with BV till the disease progression or death from any cause.
Adverse events (AEs)/serious AEs At 3, 6, 9 and 12 months of BV treatment The analysis of safety of BV will include reporting adverse events (AEs)/serious AEs (SAEs). For adverse events assessment the NCI CTCAE v. 4.0 will be used. The incidence and severity of any AEs/SAEs will be evaluated within the study
Overall response rate At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation Tumor response will be assessed and derived using the RESIST criteria v. 1.0.
Trial Locations
- Locations (9)
Almazov National Medical Research Centre
🇷🇺Saint Petersburg, Russian Federation
Tula Regional Clinical Hospital
🇷🇺Tula, Russian Federation
Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan
🇷🇺Kazan, Russian Federation
N.I. Pirogov National Medical Surgical Center
🇷🇺Moscow, Russian Federation
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
🇷🇺Chelyabinsk, Russian Federation
Clinical Onclological Center
🇷🇺Omsk, Russian Federation
Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, I. P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia
🇷🇺Saint Petersburg, Russian Federation
Department of occupational pathology, hematology and clinical pharmacology, V.I. Rasymovsky Saratov State Medical University
🇷🇺Saratov, Russian Federation
Primorskiy Regional Oncologic Center
🇷🇺Vladivostok, Russian Federation