A Study of People With CD30 Positive Lymphoma in China

NCT ID: NCT05506774

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1006 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2024-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Drug Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A: Participants With cHL.

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.

No interventions assigned to this group

Cohort B: Participants With NHL.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status

Union Hospital AffiliatedProf to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Jiangsu Province Hospital/the Firstaffiliated Hospital Withnanjing Medical University

Nanjing, Jiangsu, China

Site Status

The Firstaffiliated Hospital Ofsoochow University

Suzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)

Shandong, Jinan, China

Site Status

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C25028

Identifier Type: -

Identifier Source: org_study_id