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

January 8, 2024 updated by: Grupo Argentino de Tratamiento de la Leucemia Aguda

Real World Evidence of Brentuximab Vedotin Consolidation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Caba, Argentina
        • Recruiting
        • CEMIC
        • Contact:
          • Juan Altuve, Dr.
      • Caba, Argentina
        • Recruiting
        • Fundaleu
        • Contact:
      • Caba, Argentina
        • Recruiting
        • FLEMING
        • Contact:
          • Laura Korin, Dr.
      • Caba, Argentina
        • Recruiting
        • Hospital Aleman
        • Contact:
          • Carolina Mahuad, Dr.
      • Caba, Argentina
        • Recruiting
        • Instituto de Trasplantes de Alta Complejidad
        • Contact:
          • María Belén Rosales Ostriz, Dr.
      • Caba, Argentina
        • Recruiting
        • Sanatorio Anchorena
        • Contact:
          • Martín Castro, Dr.
      • Córdoba, Argentina
        • Recruiting
        • Clinica Universitaria Reina Fabiola
        • Contact:
          • Luciano Salvano, Dr.
      • Córdoba, Argentina
        • Recruiting
        • Hospital Privado de Cordoba
        • Contact:
          • Luciana Guanchiale, Dr.
    • Entre Ríos
      • Paraná, Entre Ríos, Argentina
        • Recruiting
        • Instituto Privado de Hematologia y Hemoterapia
        • Contact:
          • Florencia Negri Aranguren, Dr.
      • Paraná, Entre Ríos, Argentina
        • Recruiting
        • Hospital San Martin
        • Contact:
          • Romina Mariano, Dr.
    • Misiones
      • Posadas, Misiones, Argentina
        • Recruiting
        • Hospital Escuela de Agudos Dr. Ramón Madariaga
        • Contact:
          • Elisa Stemberg, Dr.
    • Provincia De Buenos Aires
      • El Palomar, Provincia De Buenos Aires, Argentina
        • Recruiting
        • Hospital Nacional Posadas
        • Contact:
          • Patricio Pereyra, Dr.
      • Florencio Varela, Provincia De Buenos Aires, Argentina
        • Recruiting
        • Hospital de Alta Complejidad El Cruce
        • Contact:
          • Soledad Cruset, Dr.
      • La Plata, Provincia De Buenos Aires, Argentina
        • Recruiting
        • Hospital Italiano de La Plata
        • Contact:
          • Lorena Fiad, Dr.
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Recruiting
        • IDHEA Clínica Hematológica
        • Contact:
          • Amalia Cerutti, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with relapsed/ refractory HL who receive ASCT from main transplant centers in Argentina

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate proportion of patients who received Brentuximab Vedotin and ASCT.
Time Frame: 24 months
Study real world evidence of the proportion and characteristics of patients with relapsed refractory cHLwho undergo ASCT, who receive consolidation with BV.
24 months
Evaluate factors that determine BV consolidation after ASCT.
Time Frame: 24 months
Study the factors that determine BV consolidation after ASCT in real world setting.
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS of the whole patient population.
Time Frame: 24 months
24 months
OS of the whole patient population.
Time Frame: 24 months
24 months
PFS of patients after ASCT who receive consolidation with BV.
Time Frame: 24 months
24 months
OS of patients after ASCT who receive consolidation with BV.
Time Frame: 24 months
24 months
PFS of patients after ASCT who do not receive consolidation with BV.
Time Frame: 24 months
24 months
OS of patients after ASCT who do not receive consolidation with BV.
Time Frame: 24 months
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
24 months
OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Time Frame: 24 months
24 months
Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Argentino de Tratamiento de la Leucemia Aguda

Collaborators

Takeda

Investigators

  • Principal Investigator: Lorena Fiad, Grupo Argentino de Tratamiento de la Leucemia Aguda
  • Principal Investigator: Florencia Negri Aranguren, Grupo Argentino de Tratamiento de la Leucemia Aguda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GATLA RR-HL-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share study protocol

IPD Sharing Time Frame

The data will become available on May 2021, and will remain available until the end of the clinical trial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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