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

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ClinicalTrials.gov Identifier: NCT03942263
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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
Hodgkin Disease Lymphoma, Large-cell, Anaplastic

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 3000 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.


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Study Type : Observational
Estimated Enrollment : 3000 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 31, 2019
Estimated Primary Completion Date : May 10, 2023
Estimated Study Completion Date : May 10, 2023


Group/Cohort
Newly Diagnosed and RR cHL Participants
Participants diagnosed with RR cHL at the time of enrollment and RR cHL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed cHL, or RR cHL at the time of enrolment, or RR cHL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting.
Newly Diagnosed and RR sALCL Participants
Participants diagnosed with RR sALCL at the time of enrollment and RR sALCL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed sALCL, or RR sALCL at the time of enrolment, or RR sALCL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting.



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-autoSCT 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) ]
  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/Recovery (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 initiation of cHL or sALCL treatment 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 initiation of cHL or sALCL treatment until the date of death from any cause or till the latest date of participant observed.

  2. Disease Free Survival (DSF) [ Time Frame: From date of full remission up to relapse or till the latest date of participant observed (up to Month 24) ]
    DSF is defined as the time from the date of full remission till relapse or till the latest date of participant observed.

  3. Freedom From Treatment Failure (FFTF) [ 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 complications, death from any cause or till observed (up to Month 24) ]
    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.

  4. Event Free Survival (EFS) [ 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 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.

  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 Participant After two and More 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. Regression of Disease free survival (DFS) After the Treatment Line Including Brentuximab Vedotin on the Number of Courses of Brentuximab Vedotin Performed Within the 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) ]
    DFS will be assessed after the treatment line including brentuximab vedotin on the number of courses of brentuximab vedotin performed within the Treatment Regimen. DFS is defined as the time from the date of full remission till relapse or till the latest date of participant observed.

  16. Regression of FFTF on the Number Courses of Brentuximab Vedotin Performed [ 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 on the number courses of brentuximab vedotin performed. 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. Regression of EFS on the Number Courses of Brentuximab Vedotin Performed [ 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 on the number courses of brentuximab vedotin performed. 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. Regression of Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen on the Number of the Courses of Brentuximab Vedotin Performed Within This 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 RECIST 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.

  19. Regression of Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen on the Number of the Courses of Brentuximab Vedotin Performed Within This 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 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. Regression of Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved on the Number of Courses of Brentuximab Vedotin Preformed Within This 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) ]
    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 and 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 disease, prognostic risk factors, and risk factors for relapse.

  23. Distribution of Clinical Variables for cHL at the Time of Primary Diagnosis and 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 histological types, immunophenotyping data (yes/no), International Prognostic Score (IPS) score.

  24. Distribution of Clinical Variables for sALCL at the Time of Primary Diagnosis and 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 immunophenotype, anaplastic lymphoma kinase (ALK)-status, prognostic index for T-cell lymphomas (PIT), IPI score and their components.

  25. Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Interim 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) ]
  26. 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) ]
  27. Regression of OS on use of PET/CT Scan for initial disease staging, interim response assessment during frontline treatment and completeness of response assessment during frontline 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.

  28. Regression of OS on Correctness of Using PET/CT Scan for Initial Disease Staging, Interim Response Assessment During Frontline Treatment and Completeness of Response Assessment During Frontline 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.

  29. Time-point of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time After the Last Cycle of Chemotherapy) [ 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) ]
    Time-points will include number of cycle after which the evaluation is performed and time after the last cycle of chemotherapy.

  30. Percentage of Participants for Whom PET and PET/CT Scan Were Used to Confirm Completeness of 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) ]
  31. Time-point of Performing Completeness if Response Evaluation With PET/CT Scan (Time From the Last Cycle of Chemotherapy) [ 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) ]
    Time-points will include time after the last cycle of chemotherapy.

  32. Percentage of Participants for Whom PET and PET/CT Were Used for Disease Control in 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) ]
  33. 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) ]
  34. 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) ]
  35. 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) ]
  36. 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) ]
  37. Frequency of Visits for Disease Control 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) ]
  38. Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Disability Determination, 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, disability determination and sick leave sheet.

  39. 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) ]
  40. 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) ]
  41. 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) ]
  42. 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) ]


Information from the National Library of Medicine

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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. Morphologically 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, multicentre, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942263


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Russian Federation
State budgetary healthcare institution of the Astrakhan region Alexander-Mariinsky regional clinical hospital Recruiting
Astrakhan, Russian Federation, 414056
State budgetary health care institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine" Not yet recruiting
Chelyabinsk, Russian Federation, 454087
State Budget Public Health Institution "Regional Oncological Dispensary", Irkutsk Recruiting
Irkutsk,, Russian Federation, 664035
Kaluga Regional Clinical Oncologic Dispensary Not yet recruiting
Kaluga, Russian Federation, 248007
Tatarstan Regional Clinical Cancer Center Recruiting
Kazan, Russian Federation, 420029
Regional State Budgetary Institution of Health "Regional Clinical Hospital 1" named after Professor S.I. Sergeeva, Ministry of Health of the Khabarovsk Territory Not yet recruiting
Khabarovsk, Russian Federation, 680009
Regional State Budgetary Institution of Healthcare Krasnoyarsk Regional Clinical Oncologic Dispensary named after A.I. Kryzhanovsky" Not yet recruiting
Krasnoyarsk, Russian Federation, 660133
Federal State Budgetary Institution "National Medical-Surgical Center named after N.I. Pirogov" Ministry of Health of the Russian Federation Recruiting
Moscow, Russian Federation, 105203
The Moscow State Clinical Hospital No. 52 of the Moscow City Department of Healthcare, State Budgetary Institution of Health Care Recruiting
Moscow, Russian Federation, 123182
Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation Recruiting
Rostov-on-Don, Russian Federation, 344022
State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital Recruiting
St. Petersburg, Russian Federation, 194291
State Healthcare Institution of Tula Region "Tula Regional Clinical Hospital" Recruiting
Tula, Russian Federation, 300053
State autonomous health care institution of the Tyumen region "Multidisciplinary clinical medical center "Medical City" Not yet recruiting
Tyumen, Russian Federation
Ministry of Health of the Republic of Bashkortostan State Autonomous Healthcare Institution Republican Clinical Oncologic Dispensary Recruiting
Ufa, Russian Federation, 450054
State budgetary health care institution "Volgograd Regional Clinical Oncology Center" Recruiting
Volgograd, Russian Federation, 400138
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03942263     History of Changes
Other Study ID Numbers: CHL-5004
U1111-1229-0611 ( Registry Identifier: WHO )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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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:
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Lymphoma
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin