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

October 25, 2019 updated by: Multinational Center for Quality of Life Research, Russia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
        • Contact:
        • Contact:
      • Kazan, Russian Federation
        • Recruiting
        • Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan
        • Contact:
      • Moscow, Russian Federation
        • Recruiting
        • N.I. Pirogov National Medical Surgical Center
        • Contact:
      • Omsk, Russian Federation
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Almazov National Medical Research Centre
        • Contact:
      • Saint Petersburg, Russian Federation
        • 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
      • Saratov, Russian Federation
        • Recruiting
        • Department of occupational pathology, hematology and clinical pharmacology, V.I. Rasymovsky Saratov State Medical University
        • Contact:
        • Contact:
      • Tula, Russian Federation
      • Vladivostok, Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QoL and symptom severity while treatment with BV
Time Frame: 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.
At 3, 6, 9 and 12 months of BV treatment and at 15 months after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: 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.
At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation
Progression-free survival (PFS)
Time Frame: 15 months
PFS will be estimated from initiation of treatment with BV till the disease progression or death from any cause.
15 months
Adverse events (AEs)/serious AEs
Time Frame: 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
At 3, 6, 9 and 12 months of BV treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multinational Center for Quality of Life Research, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 2, 2018

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (ACTUAL)

February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISR-2017-102112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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