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

NCT03440788 | Unknown

• 1 other identifier: IISR-2017-102112
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 9

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.

Conditions

Relapsed or Refractory Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Change in QoL and symptom severity while treatment with BV

  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 Outcomes (3)

• Overall response rate

  At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation

• Progression-free survival (PFS)

  15 months

• Adverse events (AEs)/serious AEs

  At 3, 6, 9 and 12 months of BV treatment

Interventions

Brentuximab Vedotin DRUG

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Multinational Center for Quality of Life Research, Russia: lead

Study Sites (9)

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, Russia

RECRUITING

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

Kazan', Russia

RECRUITING

N.I. Pirogov National Medical Surgical Center

Moscow, Russia

RECRUITING

Clinical Onclological Center

Omsk, Russia

RECRUITING

Almazov National Medical Research Centre

Saint Petersburg, Russia

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, Russia

RECRUITING

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

Saratov, Russia

RECRUITING

Tula Regional Clinical Hospital

Tula, Russia

RECRUITING

Primorskiy Regional Oncologic Center

Vladivostok, Russia

RECRUITING

MeSH Terms

Conditions

Recurrence; Hodgkin Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Tatiana Nikitina, PhD

CONTACT

+7 962 710-17-12; tnikitina_74@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 22, 2018
• Study Start: April 2, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

RU (9)