Relapsed or Refractory EBV-and CD30-positive LymphomasPhase 2BretuximabNCT02388490
Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
A Phase 2 study testing brentuximab vedotin in people with Relapsed or Refractory EBV-and CD30-positive Lymphomas, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory EBV-and CD30-positive Lymphomas
- What is being tested?
- brentuximab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 25 Mar 2016to 2 Apr 2019
- 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
- Patients with relapsed or refractory EBV- and CD30-positive lymphomas
- Age ≥ 18 years
- ECOG performance status 0-2
- At least one measurable lesion based on revised Cheson's or modified SWAT criteria
- Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
- Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
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- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- Adequate hematologic function: absolute neutrophil count (ANC) ≥1,500/µL, platelet count ≥ 75,000/µL, and hemoglobin ≥8.0 g/dL unless there is known hematologic tumor marrow involvement (ANC ≥ 1,000/µL and platelet count ≥ 50,000/µL if there is known bone marrow involvement)
- Adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome and ALT or AST < 3 x ULN (AST and AST < 5 x ULN if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
- Adequate renal function: serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
- Expected survival > 3 months
Who cannot join
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
- Any serious medical or psychiatric illness
- Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
- Symptomatic neurologic disease compromising normal activities or requiring medication
- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- Known history of myocardial infarction within 1 year, NYHA class III/IV heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
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- Any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
- Any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
- Prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
- Prior exposure to CD30-targeted agents
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
- Another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam
Seoul National Unversity Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul
About this study
Official title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
Read the detailed description
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.
- Being tested
- brentuximab vedotin
- Keywords
- Brentuximab vedotin, EBV, Lymphoma
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called Adcetris
Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab vedotin | Experimental | Brentuximab vedotin is an antibody-drug conjugate (ADC) composed of the anti-CD30 chimeric immunoglobulin G1 (IgG1) monoclonal antibody cAC10 and the potent antimicrotubule drug monomethyl auristatin E connected by a protease-cleavable linker. cAC10 binds to the CD30 antigen, which has a very low expression on normal cells but is found on some tumor cells. Receives: Drug: brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas
The primary endpoint was the ORR based on the revised criteria or modified Severity Weighted Assessment Tool (SWAT) criteria in the case of cutaneous lymphomas.
Measured: One-year
Secondary outcomes (4)
To Evaluate the Safety Profile
AEs/SAEs occurring during the study period defined by CTCAE version 4.03
Measured: From the first dose of brentuximab vedotin to up to 30 days after the last dose, a total of up to approximately 366 days
To Calculate Progression-free Survival (PFS) Time
PFS as defined as the time from the date of initiation until the date of first documented progression.
Revised tumor response criteria for lymphoma(Revised Cheson) or revised SWAT and assessed by MRI except a pregnant patient whose response evaluation can be assessed by CT scan: Progression is defined using these criteria, as observation of a new lesion or an increase of 50% or more from the nadir in a previously involved site.
Measured: One-year
To Calculate the Duration of Response
The duration of response was assessed in 12 patients who had objective responses. The response continued even after the completion of the planned 16 cycles of brentuximab vedotin administration in three of these 12 patients (25%) at the time of data cut-off.
Measured: From the first dose Up to the time of data cut-off.
To Calculate Overall Survival (OS) Time
OS as defined as the time from the date of first dose until death due to any cause.
The median overall survival was obtained, but the upper value of 95% Confidence Interval was not reached at the time of data cut-off. Therefore the longest OS was 30.4 months, the follow-up duration up to the date of data cut-off.
Measured: From first dose to end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start25 Mar 2016
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
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 Relapsed or Refractory EBV-and CD30-positive LymphomasStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- Tae Min Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388490
- Sponsor's protocol ID
- X25016
- Acronym
- Bretuximab
- Status last verified
- Apr 2019
- First submitted
- 4 Feb 2015
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim M, Lee JO, Koh J, Kim TM, Lee JY, Jeon YK, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of brentuximab vedotin in patients with relapsed or refractory Epstein-Barr virus-positive and CD30-positive lymphomas. Haematologica. 2021 Aug 1;106(8):2277-2280. doi: 10.3324/haematol.2021.278301. No abstract available.
PubMed 33792222
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
- ClinicalTrials.gov ID
- NCT02388490
- Acronym / sponsor ID
- Bretuximab / X25016
- Keywords
- Brentuximab vedotin, EBV, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
Detailed description
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab vedotin | Experimental | Drug: brentuximab vedotinBrentuximab vedotin is an antibody-drug conjugate (ADC) composed of the anti-CD30 chimeric immunoglobulin G1 (IgG1) monoclonal antibody cAC10 and the potent antimicrotubule drug monomethyl auristatin E connected by a protease-cleavable linker. cAC10 binds to the CD30 antigen, which has a very low expression on normal cells but is found on some tumor cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with relapsed or refractory EBV- and CD30-positive lymphomas
- Age ≥ 18 years
- ECOG performance status 0-2
- At least one measurable lesion based on revised Cheson's or modified SWAT criteria
- Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
Key exclusion criteria (14 listed)
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
- Any serious medical or psychiatric illness
- Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
- Symptomatic neurologic disease compromising normal activities or requiring medication
- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
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: AdcetrisBrentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks. | Drug | Brentuximab vedotin |
Primary outcome
To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas
Time frame: One-year
The primary endpoint was the ORR based on the revised criteria or modified Severity Weighted Assessment Tool (SWAT) criteria in the case of cutaneous lymphomas.
4 secondary outcomes
To Evaluate the Safety Profile
Time frame: From the first dose of brentuximab vedotin to up to 30 days after the last dose, a total of up to approximately 366 days
To Calculate Progression-free Survival (PFS) Time
Time frame: One-year
To Calculate the Duration of Response
Time frame: From the first dose Up to the time of data cut-off.
To Calculate Overall Survival (OS) Time
Time frame: From first dose to end of data collection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33792222Kim M, Lee JO, Koh J, Kim TM, Lee JY, Jeon YK, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of brentuximab vedotin in patients with relapsed or refractory Epstein-Barr virus-positive and CD30-positive lymphomas. Haematologica. 2021 Aug 1;106(8):2277-2280. doi: 10.3324/haematol.2021.278301. No abstract available.
Related trials for Relapsed or Refractory EBV-and CD30-positive Lymphomas
Active, not recruitingPhase 1
Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type, Classical Hodgkin Lymphoma
RecruitingPhase 1
Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas
CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type
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.
Tae Min Kim, MD, PhD principal investigator
Seoul National University Hospital
3 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 in people with Relapsed or Refractory EBV-and CD30-positive Lymphomas, run by Seoul National University Hospital at 3 sites 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 12 inclusion and 14 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 23 Sep 2024). 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?
To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas (time frame: One-year). 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 NCT02388490, 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 23 Sep 2024.