About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation

Clinicaltrials.gov identifier NCT03942263

Recruitment Status Active, not recruiting

First Posted May 8, 2019

Last update posted February 24, 2021

Study Description

Brief summary:

The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.

  • Condition or Disease:Lymphoma, Large-cell, Anaplastic
    Hodgkin Disease
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice. The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups: - Newly Diagnosed and RR cHL Participants - Newly Diagnosed and RR sALCL Participants This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 2000 participants
  • Observational Model: Cohort
  • Time Perspective: Other
  • Official Title: KLIO - Non-interventional Multicenter Prospective and Retrospective Study to Describe Treatment Patterns and Disease Control in Patients With Classical Hodgkin's Lymphoma (cHL) and Systemic Anaplastic Large Cell Lymphoma (sALCL) in Routine Clinical Practice in the Russian Federation
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: November 2022
  • Estimated Study Completion Date: November 2022
Outcome Measures
  • Primary Outcome Measures: 1. Description of Treatment Patterns Used for cHL or sALCL [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 2. Percentage of Participants Receiving Various Chemotherapy Regimens [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 3. Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 4. Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 5. Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 6. Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 7. Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 8. Distribution of Pre-SCT Therapy Regimens [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 9. Distribution of First Line Treatment Patterns According to Prognostic Group [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 10. Distribution of Relapse/Refractory (RR) Treatment Patterns [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: From the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed (up to Month 24) ]
    OS is defined as the time passed from the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed.
  • 2. Disease Free Survival-1 (DSF1) [ Time Frame: From date of complete remission after first line of therapy up to relapse or till the latest date of participant observed (up to Month 24) ]
    DFS1 is defined as the time from the date of complete remission after first line of therapy till relapse or till the latest date of participant observed.
  • 3. Freedom From Treatment Failure-1 (FFTF1) [ Time Frame: From date of initiation first therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24) ]
    FFTF1 is defined as the time passed from date of initiation first therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed.
  • 4. Event Free Survival-1 (EFS1) [ Time Frame: From date of initiation first therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24) ]
    EFS-1 is defined as the time passed from date of initiation first line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed.
  • 5. Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    CR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis less than (<) 10 millimeter (mm).
  • 6. Percentage of Participants With Partial Remission (PR) Achieved by the end of Treatment Regimen [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    PR based on RECIST 1.1 is defined as greater than or equal to (>=) 30 percent (%) decrease in the sum of longest diameters (SLD) of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
  • 7. Percentage of Participants With Overall Response Achieved by the end of Treatment Regimen [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Overall response based on RECIST 1.1 is defined as the percentage of participants who have a PR or CR to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30% decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
  • 8. Percentage of Participants With Stable Disease (SD) Achieved by the end of Treatment Regimen [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    SD based on RECIST 1.1 is defined as changes in the SLD of targeted lesions ranging between reduction of <10% to an increase by <20% without the appearance of a new lesion, and irrespective of positron emission tomography (PET) results.
  • 9. Percentage of Participants With Progression Disease (PD) While on the Treatment [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm.
  • 10. Percentage of Participants With Relapse (Both Early [<12 Months After the end of First Line Treatment] and Late Relapses) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 11. Percentage of Participants With Primary Resistance [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 12. Percentage of Resistant Participants to the Second and Later Treatment Lines [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 13. Percentage of Participants in Whom Brentuximab Vedotin was Used [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 14. Distribution of Treatment Patterns Containing Brentuximab Vedotin in Clinical Practice [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 15. Disease Free Survival (DFS) After the Treatment Line Including Brentuximab Vedotin Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    DFS will be assessed after the treatment line including brentuximab vedotin based on the number of cycles of brentuximab vedotin performed within this Treatment Line. DFS is defined as the time from the date of complete remission till relapse or till the latest date of participant observed.
  • 16. FFTF Based on the Number of Cycles of Brentuximab Vedotin Performed Within the Treatment Line [ Time Frame: From initiation therapy date until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complication, death from any cause, or till observed (up to Month 24) ]
    FFTF will be assessed based on the number of cycles of brentuximab vedotin performed within this treatment line. FFTF is defined as the time passed from date of initiation therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed.
  • 17. EFS Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line [ Time Frame: From initiation therapy date until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24) ]
    EFS will be assessed based on the number cycles of brentuximab vedotin performed within this treatment line. EFS is defined as the time passed from date of initiation therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed.
  • 18. Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    CR based on RECIST 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
  • 19. Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Overall response is defined as the percentage of participants who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30 % decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
  • 20. Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm.
  • 21. Number of Cycles of Brentuximab Vedotin Before and After Stem Cell Transplantation (SCT) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 22. Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Clinical variable will include stage, histological types, immunohistochemistry data (yes/no), ALK-status (negative/positive), prognostic groups, prognostic risk factors (International Prognostic Score (IPS), International Prognostic Index, Age-adjusted International Prognostic Index, International T-cell Lymphoma Project Score, Prognostic Index for peripheral T-cell lymphoma unspecified [PTCL-U] [PIT]), prognostic risk factors, and risk factors for relapse.
  • 23. Distribution of Clinical Variables for cHL and sALCL at the Time of Resistance/Relapses [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Clinical variable will include stage, histological types, immunohistochemistry data (yes/no) and ALK-status (negative/positive).
  • 24. Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Primary Disease Diagnostic and Staging [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 25. Percentage of Participants for Whom PET and PET/CT Scan was Used for Interim Treatment Response Evaluation [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 26. OS Based on use of PET/CT Scan for Initial Disease Staging, Interim and Final Response Assessment During Frontline and Second Line Treatment [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    OS is defined as the time passed from the date of initiation of cHL or sALCL treatment until the date of death from any cause or till the latest date of participant observed. OS will be analyzed by Cox regression.
  • 27. Timepoint of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Timepoints will include number of cycle after which the evaluation is performed and time from the start of last cycle of therapy.
  • 28. Percentage of Participants for Whom PET and PET/CT Scan Were Used to Evaluate Final Treatment Response [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 29. Timepoint of Performing Final Response Evaluation With PET/CT scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy) [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Timepoints will include number of cycle after which the evaluation is performed and time from the start of last cycle of therapy.
  • 30. Time of Performing PET and PET/CT Scan After SCT [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 31. Distribution of Imaging Patterns Used for Primary Disease Diagnostic and Staging in Different Regions of Russia [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 32. Distribution of Imaging Patterns Used for Treatment Response Evaluation [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 33. Distribution of Imaging Patterns Used for Disease Control of the Participants Being in Remission [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 34. Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
    Healthcare resources will include hospitalizations and sick leave sheet.
  • 35. Number of Hospitalizations [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 36. Number of Days Spent on Hospital Beds [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 37. Number of Sick Leaves [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 38. Number of Days Spent on Sick Leaves [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
  • 39. Disease Free Survival-2 (DSF2) [ Time Frame: From date of complete remission after second line of therapy up to relapse or till the latest date of participant observed (up to Month 24) ]
    DFS2 is defined as the time from the date of complete remission after second line of therapy till relapse or till the latest date of participant observed.
  • 40. Freedom From Treatment Failure-2 (FFTF2) [ Time Frame: From date of initiation second therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24) ]
    FFTF2 is defined as the time passed from date of initiation second line therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed.
  • 41. Event Free Survival-2 (EFS2) [ Time Frame: From date of initiation second therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24) ]
    EFS-2 is defined as the time passed from date of initiation second line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed.
  • 42. Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice [ Time Frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Participants with newly diagnosed cHL or sALCL, or with RR cHL or RR sALCL at the time of enrollment, or with RR cHL or RR sALCL within 3 years prior to inclusion in the study will be observed both retrospectively and prospectively.
Criteria

Inclusion Criteria:

1. Male and female participants 18 years or older by the time of enrollment.

2. Histologically confirmed diagnosis of cHL or sALCL.

3. Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of
enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion
in the Study.

Exclusion Criteria:

1. Unconfirmed diagnosis of cHL or sALCL.

2. Current, previous (within the last 3 years) or planned (for the next 2 years)
participation in interventional clinical trials.

3. Participation in the non-interventional study CHL-5001 "An international,
multi-centre, non-interventional retrospective study to describe treatment pathways,
outcomes, and resource use in participants with classical Hodgkin lymphoma
(B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).

4. Participants for whom the minimum study dataset was not available from their hospital
medical records.

Contacts and Locations
Contacts
Locations
Show 15 Study Locations
Sponsors and Collaborators

Takeda

Investigators

Study Director: Medical Director Takeda

More Information
  • Responsible Party: Takeda
  • ClinicalTrials.gov Identifier: NCT03942263 History of Changes
  • Other Study ID Numbers: CHL-5004, U1111-1229-0611
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: February 24, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR)
  • Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
  • URL: https://vivli.org/ourmember/takeda/
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Takeda: Drug Therapy
  • Additional relevant MeSH terms: Lymphoma
    Hodgkin Disease
    Lymphoma, Large-Cell, Anaplastic