Evaluating Brentuximab Vedotin after Stem Cell Transplant in Hodgkin Lymphoma Patients
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 study looks at how well Brentuximab Vedotin works as a follow-up treatment for adults with Hodgkin Lymphoma after they have a stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda Academic / other |
| Locations | 15 sites (Paraná, Entre Ríos and 14 other locations) |
| Trial ID | NCT04776265 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world evidence on patients with relapsed or refractory classical Hodgkin Lymphoma (cHL) who undergo autologous stem cell transplant (ASCT) in Argentina. It will assess the characteristics of these patients and the factors influencing the use of Brentuximab Vedotin (BV) as a consolidation therapy post-ASCT. Patients will be monitored according to local clinical practices, with data collected during routine follow-ups and treatment assessments. The study will include all eligible adult patients receiving ASCT, regardless of whether they receive BV consolidation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with histologically confirmed relapsed or refractory classical Hodgkin Lymphoma undergoing ASCT.
Not a fit: Patients with relapsed or refractory Hodgkin Lymphoma who are not suitable for ASCT will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Brentuximab Vedotin as a consolidation therapy, potentially improving outcomes for patients with relapsed or refractory Hodgkin Lymphoma.
How similar studies have performed: While this approach is observational, similar studies evaluating consolidation therapies in hematological malignancies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Paraná, Entre Ríos and 14 other locations
- Hospital San Martín — Paraná, Entre Ríos, Argentina (Recruiting)
- Instituto Privado de Hematologia y Hemoterapia — Paraná, Entre Ríos, Argentina (Recruiting)
- Hospital Escuela de Agudos Dr. Ramón Madariaga — Posadas, Misiones, Argentina (Recruiting)
- Hospital Nacional Posadas — El Palomar, Provincia De Buenos Aires, Argentina (Recruiting)
- Hospital de Alta Complejidad El Cruce — Florencio Varela, Provincia De Buenos Aires, Argentina (Recruiting)
- Hospital Italiano de La Plata — La Plata, Provincia De Buenos Aires, Argentina (Recruiting)
- IDHEA Clínica Hematológica — Rosario, Santa Fe, Argentina (Recruiting)
- Cemic — Caba, Argentina (Recruiting)
- Fleming — Caba, Argentina (Recruiting)
- Fundaleu — Caba, Argentina (Recruiting)
- Hospital Alemán — Caba, Argentina (Recruiting)
- Instituto de Trasplantes de Alta Complejidad — Caba, Argentina (Recruiting)
- Sanatorio Anchorena — Caba, Argentina (Recruiting)
- Clínica Universitaria Reina Fabiola — Córdoba, Argentina (Recruiting)
- Hospital Privado de Córdoba — Córdoba, Argentina (Recruiting)
Study contacts
- Principal investigator: Lorena Fiad — Grupo Argentino de Tratamiento de la Leucemia Aguda
- Study coordinator: Astrid Pavlovsky
- Email: astridp@intramed.net
- Phone: 5491150613683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.