Refractory Hodgkin Lymphoma Clinical Trial
Official title:
Real World Evidence of Brentuximab Vedotin Consolidation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
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 | Hospital Nacional Posadas | El Palomar | Provincia De Buenos Aires |
Argentina | Hospital de Alta Complejidad El Cruce | Florencio Varela | Provincia De Buenos Aires |
Argentina | Hospital Italiano de La Plata | La Plata | Provincia De Buenos Aires |
Argentina | Hospital San Martín | Paraná | Entre Ríos |
Argentina | Instituto Privado de Hematologia y Hemoterapia | Paraná | Entre Ríos |
Argentina | Hospital Escuela de Agudos Dr. Ramón Madariaga | Posadas | Misiones |
Argentina | IDHEA Clínica Hematológica | Rosario | Santa Fe |
Lead Sponsor | Collaborator |
---|---|
Grupo Argentino de Tratamiento de la Leucemia Aguda | Takeda |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Evaluate factors that determine BV consolidation after ASCT. | Study the factors that determine BV consolidation after ASCT in real world setting. | 24 months | |
Secondary | PFS of the whole patient population. | 24 months | ||
Secondary | OS of the whole patient population. | 24 months | ||
Secondary | PFS of patients after ASCT who receive consolidation with BV. | 24 months | ||
Secondary | OS of patients after ASCT who receive consolidation with BV. | 24 months | ||
Secondary | PFS of patients after ASCT who do not receive consolidation with BV. | 24 months | ||
Secondary | OS of patients after ASCT who do not receive consolidation with BV. | 24 months | ||
Secondary | PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation. | 24 months | ||
Secondary | OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation. | 24 months | ||
Secondary | Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy. | 24 months |
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