Relapsed or Refractory Hodgkin's LymphomaNCT03440788
Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin
An observational study of Relapsed or Refractory Hodgkin's Lymphoma, run by Multinational Center for Quality of Life Research, Russia at 9 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Hodgkin's Lymphoma
- What is being tested?
- Brentuximab Vedotin
- How many people
- 70 participants
- Where
- 9 sitesRussia
- Study dates
- 2 Apr 2018to 1 May 2020
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients enrolled in clinical trials
- Patients with contraindications to BV in accordance with instruction for use
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites, 9 recruiting
- Recruiting
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Chelyabinsk
Natalia Fadeeva, MD, PhD, 89048082445@mail.ru
Maria Andrievskih, MD, masha_a2008@mail.ru
- Recruiting
Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan
Kazan'
Gulnara Husainova, MD, PhD, gulka-n@yandex.ru
- Recruiting
N.I. Pirogov National Medical Surgical Center
Moscow
Nikita Mochkin, MD, PhD, +7 910 456-87-06, nickmed@yandex.ru
- Recruiting
Clinical Onclological Center
Omsk
Vyacheslav Kurakin, MD, kurakinvi@mail.ru
Natalia Trenina, MD, natali305@mail.ru
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg
Vladimir Ivanov, MD, PhD, adondaron17@yandex.ru
- 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
Kirill Lepik, MD, PhD, lepikkv@gmail.com
- Recruiting
Department of occupational pathology, hematology and clinical pharmacology, V.I. Rasymovsky Saratov State Medical University
Saratov
Tatiana Shelekhova, MD, PhD, tshelexova@mail.ru
Dmitriy Sherstnev, MD, sherstn-dmitrij@yandex.ru
- Recruiting
Tula Regional Clinical Hospital
Tula
Elena Volodicheva, MD, PhD, elenavolodicheva@inbox.ru
- Recruiting
Primorskiy Regional Oncologic Center
Vladivostok
Mikhail Volkov, MD, PhD, kedr-prim61@mail.ru
Olga Larionova, MD, olga_larionova_1966@mail.ru
About this study
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
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.
Read the 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.
- Being tested
- Brentuximab Vedotin
- Medical subject headings
- Recurrence, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3, 6, 9 and 12 months of BV treatment and at 15 months after treatment start
Secondary outcomes (3)
Overall response rate
Tumor response will be assessed and derived using the RESIST criteria v. 1.0.
Measured: At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation
Progression-free survival (PFS)
PFS will be estimated from initiation of treatment with BV till the disease progression or death from any cause.
Measured: 15 months
Adverse events (AEs)/serious AEs
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
Measured: At 3, 6, 9 and 12 months of BV treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start2 Apr 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Multinational Center for Quality of Life Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440788
- Sponsor's protocol ID
- IISR-2017-102112
- Status last verified
- Oct 2019
- First submitted
- 8 Feb 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03440788
- Acronym / sponsor ID
- IISR-2017-102112
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Multinational Center for Quality of Life Research, RussiaUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients enrolled in clinical trials
- Patients with contraindications to BV in accordance with instruction for use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab VedotinBrentuximab 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). | Drug | – |
Primary outcome
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.
3 secondary outcomes
Overall response rate
Time frame: At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation
Progression-free survival (PFS)
Time frame: 15 months
Adverse events (AEs)/serious AEs
Time frame: At 3, 6, 9 and 12 months of BV treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Hodgkin's Lymphoma, run by Multinational Center for Quality of Life Research, Russia at 9 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Nikitina, PhD (+7 962 710-17-12, tnikitina_74@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.