A Study of People With CD30 Positive Lymphoma in China
- Conditions
- Lymphoma
- Registration Number
- NCT05506774
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1006
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Different Initial Treatments Based on Different Lines of Therapy At Day 1 of initial treatment 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).
- Secondary Outcome Measures
Name Time Method Duration of Hospital Stay Based on Different Lines of Therapy Up to 3 years and 9 months 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.
Real World Overall Response Rate (rwORR) Up to 3 years and 9 months 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.
Number of Participants Categorized Based on Clinical Characteristics Up to 2 months before the index date 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.
Real World Progression Free Survival (rwPFS) Up to 3 years and 9 months 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.
Real World Overall Survival (rwOS) Up to 3 years and 9 months 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.
Number of Hospitalization Based on Different Lines of Therapy Up to 3 years and 9 months 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.
Trial Locations
- Locations (11)
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of China Medical University
🇨🇳ShenYang, Liaoning, China
Union Hospital AffiliatedProf to Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Jiangsu Province Hospital/the Firstaffiliated Hospital Withnanjing Medical University
🇨🇳NanJing, Jiangsu, China
The Firstaffiliated Hospital Ofsoochow University
🇨🇳SuZhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)
🇨🇳Shandong, Jinan, China
Shanghai Tongji Hospital
🇨🇳Shanghai, Shanghai, China