NCT05506774

A Study of People With CD30 Positive Lymphoma in China

A Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With CD30 Positive Lymphoma in China (REALM)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,006 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim is to see how adult participants with newly diagnosed or relapsed/refractory CD30+ lymphoma responded to any previous treatment in China. The study sponsor will not be involved in how participants are treated, the study only consists of collecting demographic and clinical records information from the hospital clinical systems. Based on the diagnosis of the disease, participants will be assigned to one of the following groups and their information will be analyzed within that group respectively: * Group A: Participants diagnosed with classical Hodgkin lymphoma (cHL). * Group B: participants diagnosed with non-Hodgkin lymphoma (NHL), including systemic anaplastic large-cell lymphoma \[sALCL\], peripheral T-cell lymphoma-not otherwise specified \[PTCL-NOS\], angioimmunoblastic T-cell lymphoma \[AITL\], extranodal NK/T-cell lymphoma \[ENKTCL\], mycosis fungoides \[MF\], primary cutaneous anaplastic large cell lymphoma \[pcALCL\], diffuse large B-cell lymphoma \[DLBCL\], primary mediastinal B-cell lymphoma \[PMBCL\]).

Detailed description

This is an observational, non-interventional, retrospective study in participants with newly diagnosed or relapsed/refractory CD30+ lymphoma to describe the treatment pathways, outcomes, and resource use among adult participants. The study will enroll approximately 2800 participants. The data will be collected from participants' medical records between January 1, 2018 and March 31, 2021 and recorded in the in case report forms (CRFs). Participants will be assigned to the following two observational cohorts based on pathological diagnosis: * Cohort A: Participants with cHL * Cohort B: Participants with NHL This multi-center trial will be conducted in China. All participants will be observed for at least 6 months or until death, loss to follow-up, or end of the study, whichever occurs first.

Conditions

• Lymphoma

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2022-08-18
• Last updated: 2024-12-11

Locations

11 sites across 1 country: China