Hodgkin LymphomaPhase 2NCT01534078
Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
A Phase 2 study testing Brentuximab Vedotin and Adriamycin, vinblastine, and dacarbazine in people with Hodgkin Lymphoma, run by Massachusetts General Hospital at 4 sites in United States.
Trial summary
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Brentuximab Vedotin and Adriamycin, vinblastine, and dacarbazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2012to Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
- Non-bulky disease defined as less than 10 cm in maximal diameter
- Measurable disease greater than or equal to 1.5 cm
- ECOG performance status of 0 or 2
- Willing to use 2 effective forms of birth control
Who cannot join
- No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- Not receiving any other investigational agents
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
- No pre-existing grade 3 or greater neuropathy
- No uncontrolled intercurrent illness
- Not pregnant or breastfeeding
- No history of a different malignancy unless disease free for at least one year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hosptial
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.
The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.
In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
Read the detailed description
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).
The following test and procedures will be performed on Days 1 and 15 of each cycle:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD
After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan Follow up will include the following
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Review and Physical exam
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- CT scans
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin, Adriamycin, vinblastine, and dacarbazine
- Keywords
- non-bulky, limited stage
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called Adcetris, SGN-35, SGN35
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Adriamycin, vinblastine, and dacarbazineDrug
Also called Doxorubicin, Velban, DTIC
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine Receives: Drug: Brentuximab Vedotin; Drug: Adriamycin, vinblastine, and dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.
Measured: End of Therapy (median duration of four months)
Secondary outcomes (3)
Overall Response Rate After One Cycle of Brentuximab
The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
- CR: Disappearance of all evidence of disease
- PR: Regression of measurable disease and no new sites
Measured: 28 days
Overall Response Rate
The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.
- CR: Disappearance of all evidence of disease
- PR: Regression of measurable disease and no new sites
Measured: End of Therapy (median duration of four months)
Grade III or IV Adverse Events
A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.
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 posted16 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center and Research Institute, Seagen Inc.
- Responsible party
- Principal investigator, Jeremy Abramson, MD, Massachusetts General Hospital
- Investigators
- Jeremy Abramson, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534078
- Sponsor's protocol ID
- 11-462
- Status last verified
- Jan 2018
- First submitted
- 9 Feb 2012
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abramson JS, Arnason JE, LaCasce AS, Redd R, Barnes JA, Sokol L, Joyce R, Avigan D, Neuberg D, Takvorian RW, Hochberg EP, Bello CM. Brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine for nonbulky limited-stage classical Hodgkin lymphoma. Blood. 2019 Aug 15;134(7):606-613. doi: 10.1182/blood.2019001272. Epub 2019 Jun 11.
PubMed 31186274
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01534078
- Acronym / sponsor ID
- 11-462
- Conditions
- Hodgkin Lymphoma
- Keywords
- non-bulky, limited stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center and Research Institute, Seagen Inc.
- Study start
- Mar 2012 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Posted 30 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.
The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.
In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
Detailed description
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).
The following test and procedures will be performed on Days 1 and 15 of each cycle:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD
After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan Follow up will include the following
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Review and Physical exam
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- CT scans
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 Vedotin, Drug: Adriamycin, vinblastine, and dacarbazineBrentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
- Non-bulky disease defined as less than 10 cm in maximal diameter
- Measurable disease greater than or equal to 1.5 cm
- ECOG performance status of 0 or 2
- Willing to use 2 effective forms of birth control
Key exclusion criteria (7 listed)
- No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- Not receiving any other investigational agents
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
- No pre-existing grade 3 or greater neuropathy
- No uncontrolled intercurrent illness
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: Adcetris, SGN-35, SGN352 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg | Drug | Treatment Arm |
| Adriamycin, vinblastine, and dacarbazineAlso: Doxorubicin, Velban, DTICCombination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine | Drug | Treatment Arm |
Primary outcome
Complete Response Rate
Time frame: End of Therapy (median duration of four months)
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.
3 secondary outcomes
Overall Response Rate After One Cycle of Brentuximab
Time frame: 28 days
Overall Response Rate
Time frame: End of Therapy (median duration of four months)
Grade III or IV Adverse Events
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31186274Abramson JS, Arnason JE, LaCasce AS, Redd R, Barnes JA, Sokol L, Joyce R, Avigan D, Neuberg D, Takvorian RW, Hochberg EP, Bello CM. Brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine for nonbulky limited-stage classical Hodgkin lymphoma. Blood. 2019 Aug 15;134(7):606-613. doi: 10.1182/blood.2019001272. Epub 2019 Jun 11.
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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.
Jeremy Abramson, M.D. principal investigator
Massachusetts General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brentuximab Vedotin and Adriamycin, vinblastine, and dacarbazine in people with Hodgkin Lymphoma, run by Massachusetts General Hospital at 4 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 5 inclusion and 7 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Response Rate (time frame: End of Therapy (median duration of four months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534078, which also lists 1 linked publication.
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 20 Feb 2018.