Clinical trial NCT04776265: RWE of Brentuximab Vedotin Consolidation in Patients With RR HL Who Receive Salvage Chemotherapy and ASCT
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hodgkin Lymphoma, Adult
Relapsed Hodgkin's Disease, Adult
Refractory Hodgkin Lymphoma
Keywords: Relapsed/ Refractory Hodgkin Lymphoma
Autologous Stem Cell Transplant
Consolidation
Brentuximab Vedotin
Lead sponsor: Grupo Argentino de Tratamiento de la Leucemia Aguda
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2021-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with relapsed/ refractory HL who receive ASCT from main transplant centers in Argentina

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.

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.

Primary outcomes:
measure: Evaluate proportion of patients who received Brentuximab Vedotin and ASCT.
timeFrame: 24 months
measure: Evaluate factors that determine BV consolidation after ASCT.
timeFrame: 24 months
Secondary outcomes:
measure: PFS of the whole patient population.
timeFrame: 24 months
measure: OS of the whole patient population.
timeFrame: 24 months
measure: PFS of patients after ASCT who receive consolidation with BV.
timeFrame: 24 months
measure: OS of patients after ASCT who receive consolidation with BV.
timeFrame: 24 months
measure: PFS of patients after ASCT who do not receive consolidation with BV.
timeFrame: 24 months
measure: OS of patients after ASCT who do not receive consolidation with BV.
timeFrame: 24 months
measure: PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
timeFrame: 24 months
measure: OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
timeFrame: 24 months
measure: Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.
timeFrame: 24 months
Other outcomes:
Locations:
city: Paraná
country: Argentina
facility: Hospital San Martín
state: Entre Ríos
city: Paraná
country: Argentina
facility: Instituto Privado de Hematologia y Hemoterapia
state: Entre Ríos
city: Posadas
country: Argentina
facility: Hospital Escuela de Agudos Dr. Ramón Madariaga
state: Misiones
city: El Palomar
country: Argentina
facility: Hospital Nacional Posadas
state: Provincia De Buenos Aires
city: Florencio Varela
country: Argentina
facility: Hospital de Alta Complejidad El Cruce
state: Provincia De Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Provincia De Buenos Aires
city: Rosario
country: Argentina
facility: IDHEA Clínica Hematológica
state: Santa Fe
city: Caba
country: Argentina
facility: CEMIC
city: Caba
country: Argentina
facility: FLEMING
city: Caba
country: Argentina
facility: FUNDALEU
city: Caba
country: Argentina
facility: Hospital Alemán
city: Caba
country: Argentina
facility: Instituto de Trasplantes de Alta Complejidad
city: Caba
country: Argentina
facility: Sanatorio Anchorena
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: Córdoba
country: Argentina
facility: Hospital Privado de Córdoba
Study officials:
affiliation: Grupo Argentino de Tratamiento de la Leucemia Aguda
name: Lorena Fiad
role: PRINCIPAL_INVESTIGATOR
affiliation: Grupo Argentino de Tratamiento de la Leucemia Aguda
name: Florencia Negri Aranguren
role: PRINCIPAL_INVESTIGATOR
References: