RWE of Brentuximab Vedotin Consolidation in Patients With RR HL Who Receive Salvage Chemotherapy and ASCT

Study Overview
=================
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.

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

Conditions
-----------------
Hodgkin Lymphoma, Adult, Relapsed Hodgkin's Disease, Adult, Refractory Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Other: Evaluation of therapeutical approach after ASCT


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RR HL Who Receive Salvage Chemotherapy and ASCT<br>Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant | Other: Evaluation of therapeutical approach after ASCT<br>* Evaluation of therapeutical approach after ASCT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsed/ Refractory Hodgkin Lymphoma, Autologous Stem Cell Transplant, Consolidation, Brentuximab Vedotin