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

Recruiting

• Conditions: Hodgkin Lymphoma, Adult; Relapsed Hodgkin's Disease, Adult; Refractory Hodgkin Lymphoma
• Interventions: Other: Evaluation of therapeutical approach after ASCT

• Registration Number: NCT04776265
• Lead Sponsor: Grupo Argentino de Tratamiento de la Leucemia Aguda

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2021-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RR HL Who Receive Salvage Chemotherapy and ASCT	Evaluation of therapeutical approach after ASCT	Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
OS 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
PFS of patients after ASCT who receive consolidation with BV.	24 months
PFS of the whole patient population.	24 months
OS of patients after ASCT who receive consolidation with BV.	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

Trial Locations

Locations (15)

Hospital Italiano de La Plata; 🇦🇷 La Plata, Provincia De Buenos Aires, Argentina

CEMIC; 🇦🇷 Caba, Argentina

FLEMING; 🇦🇷 Caba, Argentina

Hospital Alemán; 🇦🇷 Caba, Argentina

Instituto de Trasplantes de Alta Complejidad; 🇦🇷 Caba, Argentina

Hospital de Alta Complejidad El Cruce; 🇦🇷 Florencio Varela, Provincia De Buenos Aires, Argentina

Hospital Nacional Posadas; 🇦🇷 El Palomar, Provincia De Buenos Aires, Argentina

Sanatorio Anchorena; 🇦🇷 Caba, Argentina

Clínica Universitaria Reina Fabiola; 🇦🇷 Córdoba, Argentina

IDHEA Clínica Hematológica; 🇦🇷 Rosario, Santa Fe, Argentina

FUNDALEU; 🇦🇷 Caba, Argentina

Hospital Privado de Córdoba; 🇦🇷 Córdoba, Argentina

Hospital San Martín; 🇦🇷 Paraná, Entre Ríos, Argentina

Hospital Escuela de Agudos Dr. Ramón Madariaga; 🇦🇷 Posadas, Misiones, Argentina

Instituto Privado de Hematologia y Hemoterapia; 🇦🇷 Paraná, Entre Ríos, Argentina