REALM: A Study of People With CD30 Positive Lymphoma in China
Study Details
Study Description
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:
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Group A: Participants diagnosed with classical Hodgkin lymphoma (cHL).
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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]).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Cohort A: Participants with cHL
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion criteria:
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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.
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Who have received anti-lymphoma treatment between January 1, 2018 and March 31, 2021.
Exclusion criteria:
- Whose demographics and clinical features are not available from medical records.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C25028