Hodgkin Lymphoma, Adult, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
Conditions
Keywords
Relapsed/ Refractory Hodgkin Lymphoma, Autologous Stem Cell Transplant, Consolidation, Brentuximab Vedotin
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.
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.
Interventions
OTHEREvaluation of therapeutical approach after ASCT
Evaluation of therapeutical approach after ASCT
Sponsors
Takeda
Grupo Argentino de Tratamiento de la Leucemia Aguda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate proportion of patients who received Brentuximab Vedotin and ASCT. | 24 months | Study real world evidence of the proportion and characteristics of patients with relapsed refractory cHLwho undergo ASCT, who receive consolidation with BV. |
| Evaluate factors that determine BV consolidation after ASCT. | 24 months | Study the factors that determine BV consolidation after ASCT in real world setting. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| PFS of the whole patient population. | 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 |
| OS of patients after ASCT who do not receive consolidation with BV. | 24 months |
| OS of the whole patient population. | 24 months |
Countries
Argentina
Contacts
Primary ContactAstrid Pavlovsky
Backup ContactPaula Freigeiro
Outcome results
None listed