Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin LymphomaBRAVONCT03766516
Registry of BrentuximabVedotinin Patients With R/R Anaplastic Large Cell Lymphoma or Classical HL
An observational study of Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to 30 Dec 2021
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Any patient planning to administer BrentuximabVedotin to treat the target disease; 2. Any patient administering BrentuximabVedotin to treat the target disease; 3. Any patient tracing BrentuximabVedotin after treating the target disease; or 4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.
Who may be able to join
- Any patient subject to one of the following at the start of treatment with BrentuximabVedotin:
- Any patient planning to administer BrentuximabVedotin to treat the target disease;
- Any patient administering BrentuximabVedotin to treat the target disease;
- Any patient tracing BrentuximabVedotin after treating the target disease; or
- Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.
Who cannot join
- If conditions for target diseases are not met.
- If conditions for target patients are not met.
- If patients do not give written consent to participate in study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center and Non-interventional Registry of BrentuximabVedotinin Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma or Classical Hodgkin Lymphoma
In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected.
Recently, there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role as a bridge therapy before stem cell transplantation has also been suggested.
Read more
Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and lymphocyte-rich type.
Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients.
Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients.
It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study.
As Korea currently lacks real-world evidence in relation to BV, this study was conducted to address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions.
- Medical subject headings
- Recurrence, Lymphoma, Large-Cell, Anaplastic, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | 1. Any patient planning to administer BrentuximabVedotin to treat the target disease. 2. Any patient administering BrentuximabVedotin to treat the target disease. 3. Any patient tracing BrentuximabVedotin after treating the target disease. 4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Rate of patients with complete response and partial response based on Lugano classification.
Measured: 3years
Secondary outcomes (3)
Response retention period
From 1st dose date of Brentuximab Vedotin to progression date.
Measured: 3years
Overall survival period
Period from start of salvage therapy with Brentuximab Vedotin to end of study.
Measured: 3years
Length of time until next treatment
Length of time from start of salvage therapy with Brentuximab Vedotin to next salvage option after progress of disease.
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Nov 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim, Seok Jin, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766516
- Sponsor's protocol ID
- 2018-06-006
- Acronym
- BRAVO
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2018
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center and Non-interventional Registry of BrentuximabVedotinin Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma or Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03766516
- Acronym / sponsor ID
- BRAVO / 2018-06-006
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 6 Dec 2018 (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.
In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected.
Recently, there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role as a bridge therapy before stem cell transplantation has also been suggested.
Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and lymphocyte-rich type.
Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients.
Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients.
It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study.
As Korea currently lacks real-world evidence in relation to BV, this study was conducted to address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –1. Any patient planning to administer BrentuximabVedotin to treat the target disease. 2. Any patient administering BrentuximabVedotin to treat the target disease. 3. Any patient tracing BrentuximabVedotin after treating the target disease. 4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Any patient planning to administer BrentuximabVedotin to treat the target disease; 2. Any patient administering BrentuximabVedotin to treat the target disease; 3. Any patient tracing BrentuximabVedotin after treating the target disease; or 4. Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.
Key inclusion criteria (5 listed)
- Any patient subject to one of the following at the start of treatment with BrentuximabVedotin:
- Any patient planning to administer BrentuximabVedotin to treat the target disease;
- Any patient administering BrentuximabVedotin to treat the target disease;
- Any patient tracing BrentuximabVedotin after treating the target disease; or
- Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.
Key exclusion criteria (3 listed)
- If conditions for target diseases are not met.
- If conditions for target patients are not met.
- If patients do not give written consent to participate in study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall response rate
Time frame: 3years
Rate of patients with complete response and partial response based on Lugano classification.
3 secondary outcomes
Response retention period
Time frame: 3years
Overall survival period
Time frame: 3years
Length of time until next treatment
Time frame: 3years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 3years). 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 7 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.