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

Last updated: October 25, 2019
Sponsor: Multinational Center for Quality of Life Research, Russia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT03440788
IISR-2017-102112
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withprescribed treatment with BV as ≥2nd line therapy, and patients with relapse afterASCT 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

Exclusion Criteria:

  • Patients enrolled in clinical trials

  • Patients with contraindications to BV in accordance with instruction for use

Study Design

Total Participants: 70
Study Start date:
April 02, 2018
Estimated Completion Date:
May 01, 2020

Study 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.

Connect with a study center

  • Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan

    Kazan,
    Russian Federation

    Active - Recruiting

  • N.I. Pirogov National Medical Surgical Center

    Moscow,
    Russian Federation

    Active - Recruiting

  • Clinical Onclological Center

    Omsk,
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Centre

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • 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

    Active - Recruiting

  • Department of occupational pathology, hematology and clinical pharmacology, V.I. Rasymovsky Saratov State Medical University

    Saratov,
    Russian Federation

    Active - Recruiting

  • Tula Regional Clinical Hospital

    Tula,
    Russian Federation

    Active - Recruiting

  • Primorskiy Regional Oncologic Center

    Vladivostok,
    Russian Federation

    Active - Recruiting

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