Skip to main content
OpenTrials
Completed

NCT Number: NCT05506774

A Study of People With CD30 Positive Lymphoma in China

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]).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Different Initial Treatments Based on Different Lines of Therapy

    Time frame: 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 outcomes

  1. Number of Participants Categorized Based on Clinical Characteristics

    Time frame: 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.

  2. Real World Overall Response Rate (rwORR)

    Time frame: 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.

  3. Real World Progression Free Survival (rwPFS)

    Time frame: 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.

  4. Real World Overall Survival (rwOS)

    Time frame: 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.

  5. Duration of Hospital Stay Based on Different Lines of Therapy

    Time frame: 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.

  6. Number of Hospitalization Based on Different Lines of Therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Acronym: REALM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.