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

Refractory Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776265
• Other study ID #: GATLA RR-HL-2020
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Grupo Argentino de Tratamiento de la Leucemia Aguda
• Contact: Astrid Pavlovsky
• Phone: 5491150613683
• Email: astridp[@]intramed.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Lymphoma
• Refractory Hodgkin Lymphoma
• Relapsed Hodgkin's Disease, Adult

Intervention

Other:
• Evaluation of therapeutical approach after ASCT
Evaluation of therapeutical approach after ASCT

Locations

Country	Name	City	State
Argentina	CEMIC	Caba
Argentina	FLEMING	Caba
Argentina	FUNDALEU	Caba
Argentina	Hospital Alemán	Caba
Argentina	Instituto de Trasplantes de Alta Complejidad	Caba
Argentina	Sanatorio Anchorena	Caba
Argentina	Clínica Universitaria Reina Fabiola	Córdoba
Argentina	Hospital Privado de Córdoba	Córdoba
Argentina	Hospital Nacional Posadas	El Palomar	Provincia De Buenos Aires
Argentina	Hospital de Alta Complejidad El Cruce	Florencio Varela	Provincia De Buenos Aires
Argentina	Hospital Italiano de La Plata	La Plata	Provincia De Buenos Aires
Argentina	Hospital San Martín	Paraná	Entre Ríos
Argentina	Instituto Privado de Hematologia y Hemoterapia	Paraná	Entre Ríos
Argentina	Hospital Escuela de Agudos Dr. Ramón Madariaga	Posadas	Misiones
Argentina	IDHEA Clínica Hematológica	Rosario	Santa Fe

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Argentino de Tratamiento de la Leucemia Aguda	Takeda

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluate factors that determine BV consolidation after ASCT.	Study the factors that determine BV consolidation after ASCT in real world setting.	24 months
Secondary	PFS of the whole patient population.		24 months
Secondary	OS of the whole patient population.		24 months
Secondary	PFS of patients after ASCT who receive consolidation with BV.		24 months
Secondary	OS of patients after ASCT who receive consolidation with BV.		24 months
Secondary	PFS of patients after ASCT who do not receive consolidation with BV.		24 months
Secondary	OS of patients after ASCT who do not receive consolidation with BV.		24 months
Secondary	PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.		24 months
Secondary	OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.		24 months
Secondary	Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.		24 months