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
1 other identifier
observational
100
1 country
15
Brief Summary
This is a multicenter, observational real world study with prospective follow up that will evaluate the treatment approach in patients with relapsed/refractory cHL who undergo ASCT in Argentina.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
15 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
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJanuary 9, 2024
January 1, 2024
2.8 years
February 25, 2021
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate proportion of patients who received Brentuximab Vedotin and ASCT.
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.
Study the factors that determine BV consolidation after ASCT in real world setting.
24 months
Secondary Outcomes (9)
PFS of the whole patient population.
24 months
OS of the whole patient population.
24 months
PFS of patients after ASCT who receive consolidation with BV.
24 months
OS of patients after ASCT who receive consolidation with BV.
24 months
PFS of patients after ASCT who do not receive consolidation with BV.
24 months
- +4 more secondary outcomes
Study Arms (1)
RR HL Who Receive Salvage Chemotherapy and ASCT
Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant
Interventions
Evaluation of therapeutical approach after ASCT
Eligibility Criteria
Adult patients with relapsed/ refractory HL who receive ASCT from main transplant centers in Argentina
You may qualify if:
- 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.
You may not qualify if:
- Patients with Relapsed/Refractory cHL not suitable for ASCT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grupo Argentino de Tratamiento de la Leucemia Agudalead
- Takedacollaborator
Study Sites (15)
Hospital Nacional Posadas
El Palomar, Buenos Aires, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Hospital de Alta Complejidad El Cruce
San Juan Bautista, Buenos Aires, Argentina
Hospital San Martín
Paraná, Entre Ríos Province, Argentina
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province, Argentina
Hospital Escuela de Agudos Dr. Ramón Madariaga
Posadas, Misiones Province, Argentina
IDHEA Clínica Hematológica
Rosario, Santa Fe Province, Argentina
CEMIC
CABA, Argentina
FLEMING
CABA, Argentina
FUNDALEU
CABA, Argentina
Hospital Alemán
CABA, Argentina
Instituto de Trasplantes de Alta Complejidad
CABA, Argentina
Sanatorio Anchorena
CABA, Argentina
Clínica Universitaria Reina Fabiola
Córdoba, Argentina
Hospital Privado de Córdoba
Córdoba, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 1, 2021
Study Start
June 1, 2021
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will become available on May 2021, and will remain available until the end of the clinical trial.
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