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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Argentino de Tratamiento de la Leucemia Aguda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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