Clinical trial NCT03440788: Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Relapsed or Refractory Hodgkin's Lymphoma
Lead sponsor: Multinational Center for Quality of Life Research, Russia
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with relapsed or refractory HL who are not candidates for ASCT and have been prescribed to treatment with BV as ≥2nd line therapy, and patients with relapse after ASCT and have been prescribed to treatment with BV. The eligibility criteria for this study are broader than for those to be treated with BV in randomized clinical trials, so as to be reflective of routine clinical practice.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients enrolled in clinical trials
* Patients with contraindications to BV in accordance with instruction for use

Primary outcomes:
measure: Change in QoL and symptom severity while treatment with BV
timeFrame: At 3, 6, 9 and 12 months of BV treatment and at 15 months after treatment start
Secondary outcomes:
measure: Overall response rate
timeFrame: At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation
measure: Progression-free survival (PFS)
timeFrame: 15 months
measure: Adverse events (AEs)/serious AEs
timeFrame: At 3, 6, 9 and 12 months of BV treatment
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan
city: Moscow
country: Russian Federation
facility: N.I. Pirogov National Medical Surgical Center
city: Omsk
country: Russian Federation
facility: Clinical Onclological Center
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: Saint Petersburg
country: Russian Federation
facility: 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
city: Saratov
country: Russian Federation
facility: Department of occupational pathology, hematology and clinical pharmacology, V.I. Rasymovsky Saratov State Medical University
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital
city: Vladivostok
country: Russian Federation
facility: Primorskiy Regional Oncologic Center
Study officials:
References: