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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    100
  • sponsor
    Grupo Argentino de Tratamiento de la Leucemia Aguda
Updated on 10 October 2021
chemotherapy regimen
brentuximab

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.

Details
Condition Relapsed Hodgkin's Disease, Adult, Refractory Hodgkin Lymphoma, Hodgkin's Disease
Treatment Evaluation of therapeutical approach after ASCT
Clinical Study IdentifierNCT04776265
SponsorGrupo Argentino de Tratamiento de la Leucemia Aguda
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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