A Study of People With CD30 Positive Lymphoma in China (REALM)

Takeda

Status: Completed

Conditions: Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05506774

C25028

Details and patient eligibility

About

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]).

Full 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.

Enrollment: 1,006 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Who newly diagnosed with or refractory/relapsed with cHL, sALCL, CD30+ non-sALCL-NHL confirmed by immunochemistry with any CD30 expression (that is, PTCL-NOS, AITL, ENKTCL, MF, pcALCL, DLBCL, PMBCL) between January 1, 2018 and March 31, 2021 and only one CD30+ pathology report will be needed for CD30+ non-sALCL-NHL.
2. Who have received anti-lymphoma treatment between January 1, 2018 and March 31, 2021.

Exclusion criteria

1. Whose demographics and clinical features are not available from medical records.

Trial design

1,006 participants in 2 patient groups

Cohort A: Participants With cHL.

Description:

Participants who diagnosed with cHL between January 1, 2018 and March 31, 2021, and have demographic and clinical data available in hospital information system (HIS)/electronic medical records (EMRs) or laboratory information management will be observed retrospectively from the date of diagnosis with cHL until death, loss to follow-up, or end of the study, whichever occurs first.

Cohort B: Participants With NHL.

Description:

Participants who diagnosed with NHL between January 1, 2018 and March 31, 2021, and have demographic and clinical data available in HIS/EMRs or laboratory information management will be observed retrospectively from the date of diagnosis with NHL until death, loss to follow-up, or end of the study, whichever occurs first.