Clinical trial NCT05506774: A Study of People With CD30 Positive Lymphoma in China
Official title: A Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With CD30 Positive Lymphoma in China (REALM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-08-18
Enrollment: 1006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 \[PMBCL\]).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Different Initial Treatments Based on Different Lines of Therapy
timeFrame: At Day 1 of initial treatment
Secondary outcomes:
measure: Number of Participants Categorized Based on Clinical Characteristics
timeFrame: Up to 2 months before the index date
measure: Real World Overall Response Rate (rwORR)
timeFrame: Up to 3 years and 9 months
measure: Real World Progression Free Survival (rwPFS)
timeFrame: Up to 3 years and 9 months
measure: Real World Overall Survival (rwOS)
timeFrame: Up to 3 years and 9 months
measure: Duration of Hospital Stay Based on Different Lines of Therapy
timeFrame: Up to 3 years and 9 months
measure: Number of Hospitalization Based on Different Lines of Therapy
timeFrame: Up to 3 years and 9 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Wuhan
country: China
facility: Union Hospital AffiliatedProf to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: NanJing
country: China
facility: Jiangsu Province Hospital/the Firstaffiliated Hospital Withnanjing Medical University
state: Jiangsu
city: SuZhou
country: China
facility: The Firstaffiliated Hospital Ofsoochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shandong
country: China
facility: Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)
state: Jinan
city: ShenYang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: