A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation (KLIO)

Takeda

Status: Completed

Conditions: Lymphoma, Large-cell, Anaplastic; Hodgkin Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03942263

U1111-1229-0611 (Registry Identifier)

CHL-5004

Details and patient eligibility

About

The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.

Full description

This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice.

The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

• Newly Diagnosed and RR cHL Participants
• Newly Diagnosed and RR sALCL Participants

This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female participants 18 years or older by the time of enrollment.
2. Histologically confirmed diagnosis of cHL or sALCL.
3. Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.

Exclusion criteria

1. Unconfirmed diagnosis of cHL or sALCL.
2. Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
3. Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
4. Participants for whom the minimum study dataset was not available from their hospital medical records.

Trial design

2,000 participants in 2 patient groups

Newly Diagnosed and RR cHL Participants

Description:

Participants diagnosed with RR cHL at the time of enrollment and RR cHL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed cHL, or RR cHL at the time of enrolment, or RR cHL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting.

Newly Diagnosed and RR sALCL Participants

Description:

Participants diagnosed with RR sALCL at the time of enrollment and RR sALCL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed sALCL, or RR sALCL at the time of enrolment, or RR sALCL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting.