A Study of People With CD30 Positive Lymphoma in China

Lymphoma Clinical Trial

— REALM  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05506774
• Other study ID #: C25028
• Status: Active, not recruiting
• Start date: February 28, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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]).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2800
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital/the Firstaffiliated Hospital Withnanjing Medical University	NanJing	Jiangsu
China	Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)	Shandong	Jinan
China	Shanghai Tongji Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical University	ShenYang	Liaoning
China	The Firstaffiliated Hospital Ofsoochow University	SuZhou	Jiangsu
China	Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital AffiliatedProf to Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Categorized Based on Clinical Characteristics	Index date is defined the first treatment initiation date after enrollment regardless of treatment lines. The initial treatment is defined as the first treatment information after enrolment during the data collection, regardless of treatment lines. Clinical characteristics include the clinical staging of adult participants with initial diagnosis or relapsed/refractory CD30+ lymphoma in China will be reported.	Up to 2 months before the index date
Secondary	Real World Overall Response Rate (rwORR)	The rwORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) assessed by clinician documented in EMRs after the initial treatment. The rwORR will be determined by positron emission tomography-computed tomography (PET-CT) and computed tomography (CT) based on response criteria as per Lugano 2014.	Up to 3 years and 9 months
Secondary	Real World Progression Free Survival (rwPFS)	rwPFS is defined as the time from the initial treatment to the documented of relapsed or disease progression or death due to any cause, whichever occurs first. It will be analyzed using Kaplan-Meier method. The rwPFS will be determined by PET-CT and CT based on response criteria as per Lugano 2014.	Up to 3 years and 9 months
Secondary	Real World Overall Survival (rwOS)	rwOS is defined as the time from the date of initial treatment to the date of death from any cause. It will be analyzed using Kaplan-Meier method.	Up to 3 years and 9 months
Secondary	Duration of Hospital Stay Based on Different Lines of Therapy	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). The duration of hospital admission will be reported and categorized based on different lines of therapy.	Up to 3 years and 9 months
Secondary	Number of Hospitalization Based on Different Lines of Therapy	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). The number of hospital admission will be reported and categorized based on different lines of therapy.	Up to 3 years and 9 months