A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation
KLIO
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
2 other identifiers
observational
2,000
1 country
50
Brief Summary
The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
May 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2022
CompletedJuly 15, 2024
July 1, 2024
3.5 years
May 7, 2019
July 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Description of Treatment Patterns Used for cHL or sALCL
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)
Percentage of Participants Receiving Various Chemotherapy Regimens
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)
Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines
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)
Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing
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)
Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT)
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)
Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons)
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)
Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT)
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)
Distribution of Pre-SCT Therapy Regimens
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)
Distribution of First Line Treatment Patterns According to Prognostic Group
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)
Distribution of Relapse/Refractory (RR) Treatment Patterns
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 Outcomes (42)
Overall Survival (OS)
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)
Disease Free Survival-1 (DSF1)
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)
Freedom From Treatment Failure-1 (FFTF1)
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)
Event Free Survival-1 (EFS1)
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)
Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen
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 more secondary outcomes
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- Male and female participants 18 years or older by the time of enrollment.
- Histologically confirmed diagnosis of cHL or sALCL.
You may not qualify if:
- Unconfirmed diagnosis of cHL or sALCL.
- Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
- 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).
- Participants for whom the minimum study dataset was not available from their hospital medical records.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (50)
State budgetary healthcare institution of the Astrakhan region Alexander-Mariinsky regional clinical hospital
Astrakhan, 414056, Russia
Autonomous Institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of Chuvashia
Cheboksary, 428020, Russia
State budgetary health care institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine"
Chelyabinsk, 454087, Russia
State Budget Public Health Institution "Regional Oncological Dispensary"
Irkutsk, 664035, Russia
Kaluga Regional Clinical Oncologic Dispensary
Kaluga, 248007, Russia
Tatarstan Regional Clinical Cancer Center
Kazan', 420029, Russia
State budgetary institution of health care of the Kemerovo region "Regional Clinical Oncology Center"
Kemerovo, 650036, Russia
Regional State Budgetary Institution of Health "Regional Clinical Hospital 1" named after Professor S.I. Sergeeva, Ministry of Health of the Khabarovsk Territory
Khabarovsk, 680009, Russia
Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency"
Kirov, 610027, Russia
Regional State Budgetary Institution of Health "Kostroma Oncological Dispensary"
Kostroma, 156005, Russia
Regional State Budgetary Institution of Health "Regional Clinical Hospital"
Krasnoyarsk, 660022, Russia
Regional State Budgetary Institution of Healthcare Krasnoyarsk Regional Clinical Oncologic Dispensary named after A.I. Kryzhanovsky"
Krasnoyarsk, 660133, Russia
Public health institution Lipetsk Regional Oncology Center
Lipetsk, 398005, Russia
State budgetary health care institution "Regional Oncology Center 2"
Magnitogorsk, 455001, Russia
Federal State Budgetary Institution "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation
Moscow, 105094, Russia
Federal State Budgetary Institution "National Medical-Surgical Center named after N.I. Pirogov" Ministry of Health of the Russian Federation
Moscow, 105203, Russia
Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Blokhina "of the Ministry of Health of the Russian Federation
Moscow, 115478, Russia
The Moscow State Clinical Hospital No. 52 of the Moscow City Department of Healthcare, State Budgetary Institution of Health Care
Moscow, 123182, Russia
Federal State Institution National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation
Moscow, 125167, Russia
Moscow City Hematology Center on the basis of the State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital named after S.P. Botkin Moscow Department of Health
Moscow, 125284, Russia
State Budgetary Institution of Healthcare of the Moscow Region Moscow Regional Research Clinical Institute named after M.F. Vladimirskoye
Moscow, 129110, Russia
State Budgetary Healthcare Facility of Nizhny Novgorod Region "City Clinical Hospital 12"
Nizhny Novgorod, 603005, Russia
State budgetary institution of health care of the Nizhny Novgorod region "Regional Clinical Hospital named after NA Semashko"
Nizhny Novgorod, 603126, Russia
State Budgetary Institution of Healthcare of the Novosibirsk Region "City Clinical Hospital No. 2"
Novosibirsk, 630051, Russia
Federal State Budgetary Institution of Public Health of the Novosibirsk Region "Research Institute of Fundamental and Clinical Immunology"
Novosibirsk, 630075, Russia
State Budgetary Institution of Healthcare of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, 630087, Russia
Medical Radiological Research Center. A.F. Tsyba - a branch of the Federal State Budgetary Institution "Scientific Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation
Obninsk, 249031, Russia
Budget institution of healthcare of Omsk region "Clinical Oncologic dispensary"
Omsk, 644013, Russia
State budgetary institution of public health "Orenburg regional clinical hospital 1"
Orenburg, 460018, Russia
The State Budgetary Institution of Healthcare "Regional Oncologic Dispensary"
Penza, 440071, Russia
State Budgetary Institution of Healthcare of the Republic of Karelia Republican Hospital named after V. A. Baranova "
Petrozavodsk, 185019, Russia
State Budgetary Institution of Healthcare "Pskov Regional Clinical Oncologic Dispensary"
Pskov, 180004, Russia
Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation
Rostov-on-Don, 344022, Russia
Federal State Budgetary Educational Institution of Higher Education Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation
Ryazan, 390026, Russia
Federal State Budgetary Educational Institution of Higher Education "North-Western State Medical University named after II Mechnikov" of the Ministry of Health of the Russian Federation
Saint Petersburg, 191015, Russia
Federal State Budgetary Institution "Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency"
Saint Petersburg, 191024, Russia
Federal State Budgetary Institution "N. N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of Russia
Saint Petersburg, 191124, Russia
State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
Saratov State Medical University named after V.I.Razumovsky of the Ministry of Health of Russia "Clinic of Physiopathology and Hematology named after Professor V.Ya. Shustov"
Saratov, 410028, Russia
Study State Budgetary Institution of Health "Oncology Dispensary No. 2" of the Ministry of Health of the Krasnodar Territory
Sochi, 354057, Russia
State Budgetary Institution of Healthcare of the Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
Stavropol, 355047, Russia
Budgetary institution of the Khanty-Mansiysk Autonomous Okrug Ugra
Surgut, 628408, Russia
State institution of the Komi Republic "Komi Republican Oncological Dispensary"
Syktyvkar, 167904, Russia
State Healthcare Institution of Tula Region "Tula Regional Clinical Hospital"
Tula, 300053, Russia
State autonomous health care institution of the Tyumen region "Multidisciplinary clinical medical center "Medical City"
Tyumen, 625041, Russia
Ministry of Health of the Republic of Bashkortostan State Autonomous Healthcare Institution Republican Clinical Oncologic Dispensary
Ufa, 450054, Russia
State Healthcare Institution "Regional Clinical Oncologic Dispensary"
Ulyanovsk, 432017, Russia
State budgetary health care institution "Volgograd Regional Clinical Oncology Center"
Volgograd, 400138, Russia
Budget institution of health care of the Vologda region "Vologda regional clinical hospital"
Vologda, 160002, Russia
State budgetary institution of health care of the Yaroslavl region "Regional Clinical Hospital"
Yaroslavl, 150062, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 8, 2019
Study Start
May 31, 2019
Primary Completion
December 8, 2022
Study Completion
December 8, 2022
Last Updated
July 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.