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

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ClinicalTrials.gov Identifier: NCT03440788
Recruitment Status : Not yet recruiting
First Posted : February 21, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Multinational Center for Quality of Life Research, Russia

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.

Condition or disease Intervention/treatment
Relapsed or Refractory Hodgkin's Lymphoma Drug: Brentuximab Vedotin

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
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
Estimated Study Start Date : March 31, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Brentuximab Vedotin
    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).


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Additional Information:

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Responsible Party: Multinational Center for Quality of Life Research, Russia
ClinicalTrials.gov Identifier: NCT03440788     History of Changes
Other Study ID Numbers: IISR-2017-102112
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs