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

Relapsed or Refractory Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03440788
• Other study ID #: IISR-2017-102112
• Status: Recruiting
• Start date: April 2, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: October 2019
• Source: Multinational Center for Quality of Life Research, Russia
• Contact: Tatiana Nikitina, PhD
• Phone: +7 962 710-17-12
• Email: tnikitina_74[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Relapsed or Refractory Hodgkin's Lymphoma

Intervention

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).

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine	Chelyabinsk
Russian Federation	Republican Clinical Oncology Center of the Ministry of Health of the Republic of Tatarstan	Kazan
Russian Federation	N.I. Pirogov National Medical Surgical Center	Moscow
Russian Federation	Clinical Onclological Center	Omsk
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg
Russian Federation	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	Department of occupational pathology, hematology and clinical pharmacology, V.I. Rasymovsky Saratov State Medical University	Saratov
Russian Federation	Tula Regional Clinical Hospital	Tula
Russian Federation	Primorskiy Regional Oncologic Center	Vladivostok

Sponsors (1)

Lead Sponsor	Collaborator
Multinational Center for Quality of Life Research, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response rate	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
Secondary	Progression-free survival (PFS)	PFS will be estimated from initiation of treatment with BV till the disease progression or death from any cause.	15 months
Secondary	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	At 3, 6, 9 and 12 months of BV treatment