- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04776265
RWE of Brentuximab Vedotin Consolidation in Patients With RR HL Who Receive Salvage Chemotherapy and ASCT
Real World Evidence of Brentuximab Vedotin Consolidation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of the study is to gather real world evidence of the proportion and characteristics of patients with relapsed refractory cHL who undergo ASCT, who receive consolidation with BV, and to study the factors that determine BV consolidation after ASCT in real world setting.
This study will evaluate the treatment approach in patients with relapsed/refractory cHL who undergo ASCT. All consecutive adult patients with relapsed/refractory cHL who undergo ASCT, regardless of the prior indication to receive or not BV consolidation therapy, will be included in this study and prospectively followed according to local practice.
Patients will be treated and monitored by their physicians according to local clinical practice and guided by the local approved label for patients receiving BV consolidation. Usual follow-up will be determined by the treating physicians' standards of care, and no scheduled patient visits are required for the conduct of this study. There are no visits or specific procedures planned by protocol, however, baseline and follow up data will be gathered every time the patient's response to treatment is assessed or has a medically important event.
All patients that undergo ASCT will be included in final analysis of the primary objectives (Full study population). Patients that receive BV consolidation or not (Non-BV consolidation) will be included in the analysis.
Patients included in the study are expected to be recruited during 24 months and followed up to progression, death, lost to follow or end of study (12 months after the inclusion of the last patient), whatever occurs earlier.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paula Freigeiro
- Email: gatla.ar@gmail.com
Study Contact Backup
- Name: Astrid Pavlovsky
- Phone Number: 5491150613683
- Email: astridp@intramed.net
Study Locations
-
-
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Caba, Argentina
- Recruiting
- CEMIC
-
Contact:
- Juan Altuve, Dr.
-
Caba, Argentina
- Recruiting
- Fundaleu
-
Contact:
- Astrid Pavlovsky
- Phone Number: 5491150613683
- Email: astridp@intramed.net
-
Caba, Argentina
- Recruiting
- FLEMING
-
Contact:
- Laura Korin, Dr.
-
Caba, Argentina
- Recruiting
- Hospital Aleman
-
Contact:
- Carolina Mahuad, Dr.
-
Caba, Argentina
- Recruiting
- Instituto de Trasplantes de Alta Complejidad
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Contact:
- María Belén Rosales Ostriz, Dr.
-
Caba, Argentina
- Recruiting
- Sanatorio Anchorena
-
Contact:
- Martín Castro, Dr.
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Córdoba, Argentina
- Recruiting
- Clinica Universitaria Reina Fabiola
-
Contact:
- Luciano Salvano, Dr.
-
Córdoba, Argentina
- Recruiting
- Hospital Privado de Cordoba
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Contact:
- Luciana Guanchiale, Dr.
-
-
Entre Ríos
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Paraná, Entre Ríos, Argentina
- Recruiting
- Instituto Privado de Hematologia y Hemoterapia
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Contact:
- Florencia Negri Aranguren, Dr.
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Paraná, Entre Ríos, Argentina
- Recruiting
- Hospital San Martín
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Contact:
- Romina Mariano, Dr.
-
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Misiones
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Posadas, Misiones, Argentina
- Recruiting
- Hospital Escuela de Agudos Dr. Ramón Madariaga
-
Contact:
- Elisa Stemberg, Dr.
-
-
Provincia De Buenos Aires
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El Palomar, Provincia De Buenos Aires, Argentina
- Recruiting
- Hospital Nacional Posadas
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Contact:
- Patricio Pereyra, Dr.
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Florencio Varela, Provincia De Buenos Aires, Argentina
- Recruiting
- Hospital de Alta Complejidad El Cruce
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Contact:
- Soledad Cruset, Dr.
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La Plata, Provincia De Buenos Aires, Argentina
- Recruiting
- Hospital Italiano de la Plata
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Contact:
- Lorena Fiad, Dr.
-
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Santa Fe
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Rosario, Santa Fe, Argentina
- Recruiting
- IDHEA Clínica Hematológica
-
Contact:
- Amalia Cerutti, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients 18 years or older.
- All patients with histologically confirmed cHL who are primary refractory or relapse and receive ASCT as part of their salvage therapy.
- Signature of the form consent for participation in the study.
Exclusion Criteria:
- Patients with Relapsed/Refractory cHL not suitable for ASCT.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RR HL Who Receive Salvage Chemotherapy and ASCT
Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant
|
Evaluation of therapeutical approach after ASCT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate proportion of patients who received Brentuximab Vedotin and ASCT.
Time Frame: 24 months
|
Study real world evidence of the proportion and characteristics of patients with relapsed refractory cHLwho undergo ASCT, who receive consolidation with BV.
|
24 months
|
Evaluate factors that determine BV consolidation after ASCT.
Time Frame: 24 months
|
Study the factors that determine BV consolidation after ASCT in real world setting.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS of the whole patient population.
Time Frame: 24 months
|
24 months
|
OS of the whole patient population.
Time Frame: 24 months
|
24 months
|
PFS of patients after ASCT who receive consolidation with BV.
Time Frame: 24 months
|
24 months
|
OS of patients after ASCT who receive consolidation with BV.
Time Frame: 24 months
|
24 months
|
PFS of patients after ASCT who do not receive consolidation with BV.
Time Frame: 24 months
|
24 months
|
OS of patients after ASCT who do not receive consolidation with BV.
Time Frame: 24 months
|
24 months
|
PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Time Frame: 24 months
|
24 months
|
OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Time Frame: 24 months
|
24 months
|
Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lorena Fiad, Grupo Argentino de Tratamiento de la Leucemia Aguda
- Principal Investigator: Florencia Negri Aranguren, Grupo Argentino de Tratamiento de la Leucemia Aguda
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GATLA RR-HL-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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