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.
Study Type
OBSERVATIONAL
Enrollment
100
Evaluation of therapeutical approach after ASCT
Hospital Nacional Posadas
El Palomar, Buenos Aires, Argentina
RECRUITINGHospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
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.
Time frame: 24 months
Evaluate factors that determine BV consolidation after ASCT.
Study the factors that determine BV consolidation after ASCT in real world setting.
Time frame: 24 months
PFS of the whole patient population.
Time frame: 24 months
OS of the whole patient population.
Time frame: 24 months
PFS of patients after ASCT who receive consolidation with BV.
Time frame: 24 months
OS of patients after ASCT who receive consolidation with BV.
Time frame: 24 months
PFS of patients after ASCT who do not receive consolidation with BV.
Time frame: 24 months
OS of patients after ASCT who do not receive consolidation with BV.
Time frame: 24 months
PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Time frame: 24 months
OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
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Hospital de Alta Complejidad El Cruce
San Juan Bautista, Buenos Aires, Argentina
RECRUITINGHospital San Martín
Paraná, Entre Ríos Province, Argentina
RECRUITINGInstituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province, Argentina
RECRUITINGHospital Escuela de Agudos Dr. Ramón Madariaga
Posadas, Misiones Province, Argentina
RECRUITINGIDHEA Clínica Hematológica
Rosario, Santa Fe Province, Argentina
RECRUITINGCEMIC
CABA, Argentina
RECRUITINGFLEMING
CABA, Argentina
RECRUITINGFUNDALEU
CABA, Argentina
RECRUITING...and 5 more locations
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.
Time frame: 24 months