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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RR HL Who Receive Salvage Chemotherapy and ASCT | Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of therapeutical approach after ASCT | Other | Evaluation of therapeutical approach after ASCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with relapsed/ refractory HL who receive ASCT from main transplant centers in Argentina
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astrid Pavlovsky | Contact | 5491150613683 | astridp@intramed.net | |
| Paula Freigeiro | Contact | gatla.ar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lorena Fiad | Grupo Argentino de Tratamiento de la Leucemia Aguda | Principal Investigator |
| Florencia Negri Aranguren | Grupo Argentino de Tratamiento de la Leucemia Aguda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Posadas | Recruiting | El Palomar | Buenos Aires | Argentina |
Share study protocol
The data will become available on May 2021, and will remain available until the end of the clinical trial.
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| 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 |
| OS of patients after ASCT who do not receive consolidation with BV. | 24 months |
| PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation. | 24 months |
| OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation. | 24 months |
| Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy. | 24 months |
| Hospital Italiano de La Plata | Recruiting | La Plata | Buenos Aires | Argentina |
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| Hospital de Alta Complejidad El Cruce | Recruiting | San Juan Bautista | Buenos Aires | Argentina |
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| Hospital San Martín | Recruiting | Paraná | Entre Ríos Province | Argentina |
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| Instituto Privado de Hematologia y Hemoterapia | Recruiting | Paraná | Entre Ríos Province | Argentina |
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| Hospital Escuela de Agudos Dr. Ramón Madariaga | Recruiting | Posadas | Misiones Province | Argentina |
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| IDHEA Clínica Hematológica | Recruiting | Rosario | Santa Fe Province | Argentina |
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| CEMIC | Recruiting | CABA | Argentina |
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| FLEMING | Recruiting | CABA | Argentina |
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| FUNDALEU | Recruiting | CABA | Argentina |
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| Hospital Alemán | Recruiting | CABA | Argentina |
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| Instituto de Trasplantes de Alta Complejidad | Recruiting | CABA | Argentina |
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| Sanatorio Anchorena | Recruiting | CABA | Argentina |
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| Clínica Universitaria Reina Fabiola | Recruiting | Córdoba | Argentina |
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| Hospital Privado de Córdoba | Recruiting | Córdoba | Argentina |
|
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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