Hodgkin Lymphoma, AdultNCT04776265
RWE of Brentuximab Vedotin Consolidation in Patients With RR HL Who Receive Salvage Chemotherapy and ASCT
An observational study of Hodgkin Lymphoma, Adult and Relapsed Hodgkin's Disease, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 15 sites in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Adult, Relapsed Hodgkin's Disease, Adult, Refractory Hodgkin Lymphoma
- What is being tested?
- Evaluation of therapeutical approach after ASCT
- How many people
- 100 participants
- Where
- 15 sitesArgentina
- Study dates
- 1 Jun 2021to 1 Apr 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with relapsed/ refractory HL who receive ASCT from main transplant centers in Argentina
Who may be able to join
- 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.
Who cannot join
- Patients with Relapsed/Refractory cHL not suitable for ASCT.
Trial locations and contacts
15 sites in 1 country.
Paula Freigeiro contact
15 sites in 1 country
Argentina15 sites, 15 recruiting
- Recruiting
CEMIC
CABA
Juan Altuve, Dr.
- Recruiting
FLEMING
CABA
Laura Korin, Dr.
- Recruiting
FUNDALEU
CABA
Astrid Pavlovsky, 5491150613683, astridp@intramed.net
- Recruiting
Hospital Alemán
CABA
Carolina Mahuad, Dr.
- Recruiting
Instituto de Trasplantes de Alta Complejidad
CABA
María Belén Rosales Ostriz, Dr.
- Recruiting
Sanatorio Anchorena
CABA
Martín Castro, Dr.
- Recruiting
Clínica Universitaria Reina Fabiola
Córdoba
Luciano Salvano, Dr.
- Recruiting
Hospital Privado de Córdoba
Córdoba
Luciana Guanchiale, Dr.
- Recruiting
Hospital Nacional Posadas
El Palomar, Buenos Aires
Patricio Pereyra, Dr.
- Recruiting
Hospital Italiano de La Plata
La Plata, Buenos Aires
Lorena Fiad, Dr.
- Recruiting
Hospital San Martín
Paraná, Entre Ríos Province
Romina Mariano, Dr.
- Recruiting
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province
Florencia Negri Aranguren, Dr.
- Recruiting
Hospital Escuela de Agudos Dr. Ramón Madariaga
Posadas, Misiones Province
Elisa Stemberg, Dr.
- Recruiting
IDHEA Clínica Hematológica
Rosario, Santa Fe Province
Amalia Cerutti, Dr.
- Recruiting
Hospital de Alta Complejidad El Cruce
San Juan Bautista, Buenos Aires
Soledad Cruset, Dr.
About this study
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
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.
Read the 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.
- Being tested
- Evaluation of therapeutical approach after ASCT
- Keywords
- Relapsed/ Refractory Hodgkin Lymphoma, Autologous Stem Cell Transplant, Consolidation, Brentuximab Vedotin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of therapeutical approach after ASCTOther
Evaluation of therapeutical approach after ASCT
| Study group | Role | What they receive |
|---|---|---|
| RR HL Who Receive Salvage Chemotherapy and ASCT | Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant Receives: Other: Evaluation of therapeutical approach after ASCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Evaluate factors that determine BV consolidation after ASCT.
Study the factors that determine BV consolidation after ASCT in real world setting.
Measured: 24 months
Secondary outcomes (9)
PFS of the whole patient population.
Measured: 24 months
OS of the whole patient population.
Measured: 24 months
PFS of patients after ASCT who receive consolidation with BV.
Measured: 24 months
OS of patients after ASCT who receive consolidation with BV.
Measured: 24 months
PFS of patients after ASCT who do not receive consolidation with BV.
Measured: 24 months
OS of patients after ASCT who do not receive consolidation with BV.
Measured: 24 months
PFS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Measured: 24 months
OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Measured: 24 months
Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jun 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Lorena Fiad, Principal investigator, Grupo Argentino de Tratamiento de la Leucemia AgudaFlorencia Negri Aranguren, Principal investigator, Grupo Argentino de Tratamiento de la Leucemia Aguda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776265
- Sponsor's protocol ID
- GATLA RR-HL-2020
- Status last verified
- Jan 2024
- First submitted
- 25 Feb 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share study protocol
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04776265
- Acronym / sponsor ID
- GATLA RR-HL-2020
- Keywords
- Relapsed/ Refractory Hodgkin Lymphoma, Autologous Stem Cell Transplant, Consolidation, Brentuximab Vedotin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia AgudaUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RR HL Who Receive Salvage Chemotherapy and ASCT | – | Other: Evaluation of therapeutical approach after ASCTPatients With Relapsed/Refractory Classical Hodgkin Lymphoma Who Receive Salvage Chemotherapy and Autologous Stem Cell Transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with relapsed/ refractory HL who receive ASCT from main transplant centers in Argentina
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with Relapsed/Refractory cHL not suitable for ASCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of therapeutical approach after ASCTEvaluation of therapeutical approach after ASCT | Other | RR HL Who Receive Salvage Chemotherapy and ASCT |
Primary outcome
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.
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.
9 secondary outcomes
PFS of the whole patient population.
Time frame: 24 months
OS of the whole patient population.
Time frame: 24 months
PFS of patients after ASCT who receive consolidation with BV.
Time frame: 24 months
OS of patients after ASCT who receive consolidation with BV.
Time frame: 24 months
PFS of patients after ASCT who do not receive consolidation with BV.
Time frame: 24 months
OS of patients after ASCT who do not receive consolidation with BV.
Time frame: 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
OS according to PET status at time of ASCT, and other risk factors in patients who receive BV consolidation.
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events of BV consolidation therapy.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. Share study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Freigeiro contact
Lorena Fiad principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
Florencia Negri Aranguren principal investigator
Grupo Argentino de Tratamiento de la Leucemia Aguda
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, Adult and Relapsed Hodgkin's Disease, Adult, run by Grupo Argentino de Tratamiento de la Leucemia Aguda at 15 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid Pavlovsky (5491150613683, astridp@intramed.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate proportion of patients who received Brentuximab Vedotin and ASCT. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.