A Study of People With CD30 Positive Lymphoma in China

NCT05506774 | Completed

• 1 other identifier: C25028
• Study Type: observational
• Target: 1,006
• Locations: 1 country
• Sites: 11

Brief 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 \[PMBCL\]).

Conditions

Lymphoma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Different Initial Treatments Based on Different Lines of Therapy

  The initial treatment is defined as the first treatment information after enrolment during the data collection, regardless of treatment lines. Initial treatments will include but not limited to the following: chemotherapy, radiotherapy, targeted therapy, immunotherapy, autologous stem cell transplant (ASCT), and other treatments). Different lines of therapy will include the following: the initial treatment in first-line (newly diagnosed), second-line (first refractory/relapsed), and third- or later-line (refractory/relapsed after 2 or more lines of therapies).

  At Day 1 of initial treatment

Secondary Outcomes (6)

• Number of Participants Categorized Based on Clinical Characteristics

  Up to 2 months before the index date

• Real World Overall Response Rate (rwORR)

  Up to 3 years and 9 months

• Real World Progression Free Survival (rwPFS)

  Up to 3 years and 9 months

• Real World Overall Survival (rwOS)

  Up to 3 years and 9 months

• Duration of Hospital Stay Based on Different Lines of Therapy

  Up to 3 years and 9 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with CD30+ lymphoma (newly diagnosed or refractory/relapsed) and treated between January 1, 2018 and March 31, 2021 will be enrolled in this study.

You may qualify if:

• 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.
• Who have received anti-lymphoma treatment between January 1, 2018 and March 31, 2021.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (11)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100010, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

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

Wuhan, Hubei, 430022, China

Location

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

Wuhan, Hubei, 430030, China

Location

Jiangsu Province Hospital/the Firstaffiliated Hospital Withnanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

The Firstaffiliated Hospital Ofsoochow University

Suzhou, Jiangsu, 215000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

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

Shandong, Jinan, 250000, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: February 28, 2023
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (11)