Graft vs. Host DiseasePhase 1NCT01596218
Brentuximab Vedotin for Steroid Refractory GvHD
A Phase 1 study testing Brentuximab Vedotin in people with Graft vs. Host Disease, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs. Host Disease
- What is being tested?
- Brentuximab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2012to Dec 2016
- Phase
- Phase 1
- 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
Who may be able to join
- Acute GVHD
- Corticosteroid refractory
Who cannot join
- Pregnant or breastfeeding
- Requiring mechanical ventilation
- Concurrent hepatic VOD
- Have received another study agent within 7 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ohio State University
Columbus, Ohio
Memorial Sloan Kettering Cancer Center
New York, New York
About this study
Official title: Phase I Trial of Brentuximab Vedotin for Steroid Refractory Acute Graft vs. Host Disease (GvHD)
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved brentuximab vedotin for the treatment of GVHD.
Currently, corticosteroids are the standard/first line of treatment for people with GVHD. However, some patients do not achieve a good response with steroids and other experience flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a weakening of the immune system. For this reason, there have been increased attempts by researchers to find other options for the treatment of Graft vs. Host Disease.
Read more
Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but results from other research studies show that it could help slow the growth of your disease.
In this research study, we are trying to determine the safest dose of brentuximab vedotin that can be given to patients with GVHD.
Read the detailed description
This study will be broken up into two parts: induction and maintenance. The induction phase will last for 28 days and the maintenance phase will last for 12 weeks.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have Graft vs. Host Disease, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
The induction phase of the trial involves finding the safest dose of brentuximab vedotin. In this phase, participants will receive 3 weekly doses on days 1, 8 and 15 of the cycle. Brentuximab vedotin is administered via intravenous infusion, which means directly into the vein, over a period of about 30 minutes.
Additionally you will undergo the following tests and procedures when you come into the clinic to receive your brentuximab vedotin: physical exam, medical history, performance status, routine and research blood tests, assessment for side effects and acute/chronic GVHD.
If you are still on this study at the end of the induction phase, meaning you have had no serious side effects and your GVHD has not progressed, ou wil continue to the next phase of this study.
Participants in the maintenance phase will receive a total of 4 doses of brentuximab vedotin every 3 weeks for a total of 12 weeks. Day 1 of the maintenance phase will be the day after the 28 day induction phase ends. You will receive a dose of brentuximab vedotin via IV infusion on Day 1 of Weeks 1,4, 7 and 10. During these visits you will undergo the same tests, procedures and assessments as the induction phase.
You will have three follow up visits after your last dose of brentuximab vedotin at 6 months, 9 months and 12 months after the end of the maintenance phase. You also have the option to talk to your physician about continuing treatment with brentuximab vedotin. However, brentuximab vedotin will only be provided by the study for the 12 week maintenance period. Afterward, brentuximab vedotin will need to be covered by your insurance or paid for out of pocket.
- Conditions
- Graft vs. Host Disease
- Being tested
- Brentuximab Vedotin
- Keywords
- Steroid Refractory, Acute
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called SGN-35
Starting dose is 0.6 mg/kg weekly x 3
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treatment Arm for all participants - Brentuximab vedotin Receives: Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define MTD of Brentuximab Vedotin
To define the maximum tolerated dose (MTD) of brentuximab vedotin when given as treatment for steroid-refractory acute GVHD
Measured: 2 years
Secondary outcomes (6)
Overall Response Rate
To test the overall response rate of brentuximab vedotin when given as treatment for steroid refractory acute GVHD
Measured: 2 years
Identification of Toxicities
To identify the toxicities associated with brentuximab vedotin when used as therapy for steroid-refractory acute GVHD
Measured: 2 years
Overall Survival
Overall survival at 100 days, 180 days and one year after first infusion
Measured: 2 years
Description of Cumulative Incidence of Chronic GVHD
To describe the cumulative incidence of chronic GVHD developing in patients with acute GVHD treated with brentuximab vedotin
Measured: 2 years
Assessment of Levels of Soluble CD30
To assess levels of soluble CD30 and surface CD30 expression on peripheral blood T-cells in patients with acute GVHD before and after the administration of brentuximab vedotin
Measured: 2 years
Assessment of Steroid Dose
To assess dose of steroids (mg/kg/day of prednisone equivalent) at 6 and 12 months after starting therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs. Host DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Yi-Bin A. Chen, MD, Massachusetts General Hospital
- Investigators
- Yi-Bin Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596218
- Sponsor's protocol ID
- 12-094
- Status last verified
- Jul 2018
- First submitted
- 9 May 2012
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Brentuximab Vedotin for Steroid Refractory Acute Graft vs. Host Disease (GvHD)
- ClinicalTrials.gov ID
- NCT01596218
- Acronym / sponsor ID
- 12-094
- Conditions
- Graft vs. Host Disease
- Keywords
- Steroid Refractory, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Seagen Inc., Dana-Farber Cancer Institute
- Study start
- Jul 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 May 2012 (estimated)
- 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 research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved brentuximab vedotin for the treatment of GVHD.
Currently, corticosteroids are the standard/first line of treatment for people with GVHD. However, some patients do not achieve a good response with steroids and other experience flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a weakening of the immune system. For this reason, there have been increased attempts by researchers to find other options for the treatment of Graft vs. Host Disease.
Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but results from other research studies show that it could help slow the growth of your disease.
In this research study, we are trying to determine the safest dose of brentuximab vedotin that can be given to patients with GVHD.
Detailed description
This study will be broken up into two parts: induction and maintenance. The induction phase will last for 28 days and the maintenance phase will last for 12 weeks.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have Graft vs. Host Disease, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
The induction phase of the trial involves finding the safest dose of brentuximab vedotin. In this phase, participants will receive 3 weekly doses on days 1, 8 and 15 of the cycle. Brentuximab vedotin is administered via intravenous infusion, which means directly into the vein, over a period of about 30 minutes.
Additionally you will undergo the following tests and procedures when you come into the clinic to receive your brentuximab vedotin: physical exam, medical history, performance status, routine and research blood tests, assessment for side effects and acute/chronic GVHD.
If you are still on this study at the end of the induction phase, meaning you have had no serious side effects and your GVHD has not progressed, ou wil continue to the next phase of this study.
Participants in the maintenance phase will receive a total of 4 doses of brentuximab vedotin every 3 weeks for a total of 12 weeks. Day 1 of the maintenance phase will be the day after the 28 day induction phase ends. You will receive a dose of brentuximab vedotin via IV infusion on Day 1 of Weeks 1,4, 7 and 10. During these visits you will undergo the same tests, procedures and assessments as the induction phase.
You will have three follow up visits after your last dose of brentuximab vedotin at 6 months, 9 months and 12 months after the end of the maintenance phase. You also have the option to talk to your physician about continuing treatment with brentuximab vedotin. However, brentuximab vedotin will only be provided by the study for the 12 week maintenance period. Afterward, brentuximab vedotin will need to be covered by your insurance or paid for out of pocket.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Brentuximab VedotinTreatment Arm for all participants - Brentuximab vedotin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute GVHD
- Corticosteroid refractory
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Requiring mechanical ventilation
- Concurrent hepatic VOD
- Have received another study agent within 7 days
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 |
|---|---|---|
| Brentuximab VedotinAlso: SGN-35Starting dose is 0.6 mg/kg weekly x 3 | Drug | Treatment Arm |
Primary outcome
Define MTD of Brentuximab Vedotin
Time frame: 2 years
To define the maximum tolerated dose (MTD) of brentuximab vedotin when given as treatment for steroid-refractory acute GVHD
6 secondary outcomes
Overall Response Rate
Time frame: 2 years
Identification of Toxicities
Time frame: 2 years
Overall Survival
Time frame: 2 years
Description of Cumulative Incidence of Chronic GVHD
Time frame: 2 years
Assessment of Levels of Soluble CD30
Time frame: 2 years
Assessment of Steroid Dose
Time frame: 2 years
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 26 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Yi-Bin Chen, MD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brentuximab Vedotin in people with Graft vs. Host Disease, run by Massachusetts General Hospital at 5 sites in United States.
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 2 inclusion and 4 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Define MTD of Brentuximab Vedotin (time frame: 2 years). 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 26 Jul 2018.