Non-Hodgkin LymphomaPhase 2BRANNCT02280785
Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas
A Phase 2 study testing Brentuximab vedotin in people with Non-Hodgkin Lymphoma, run by Samsung Medical Center at 4 sites in South Korea.
Trial summary
Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies (Clin Cancer Res. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-Hodgkin Lymphoma
- 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
- 33 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2014to Sep 2018
- Phase
- Phase 2
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed non-Hodgkin lymphomas with CD 30 expression. Criteria of positive CD30 expression are defined as in cases with membranous CD30 expression from more than 50% of neoplastic cells.
- Relapsed or progressed disease after two or more than two salvage chemotherapy
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Measurable disease > 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen/pelvis or CT/positron emission tomography (PET) scans
- Life expectancy of greater than 3 months
- ECOG performance status ≤ 2
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- Male or female patients 18 - 75 years
- 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.
- 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.
- Clinical laboratory values as specified below within 7 days before the first dose of study drug:
- Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
- Hemoglobin must be ≥ 8g/dL.
- Absolute neutrophil count (ANC) ≥ 1500/uL
- Platelets (Plts) ≥ 75,000/; G-CSF can be given prior to start of brentuximab vedotin and during brentuximab vedotin treatment to achieve target ANC; platelet transfusion can also be given prior to the start of brentuximab vedotin and during brentuximab vedotin treatment to achieve a target platelet ≥ 75,000/uL
- Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 X institutional ULN. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver
Who cannot join
- Hodgkin lymphoma
- Anaplastic large cell lymphoma
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
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- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
- Any prior treatment with chemotherapy and/or investigational agents completed less than 5 half-lives
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
- Known HIV antibody-positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
- Diagnosed or treated for 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.
- Known history of any of the following cardiovascular conditions:
- Myocardial infarction within 2 years of first dose of study drug
- New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 3)
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- A left-ventricular ejection fraction <50% documented within 6 months before first dose of study drug
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Yonsei Severance Hospital
Seoul, 120-752
Asan Medical Center
Seoul, 138-736
Korean Cancer Center Hospital
Seoul, 139-706
About this study
Official title: A Phase II Study of Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas Other Than Anaplastic Large Cell Lymphoma
Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies (Clin Cancer Res. 2012) showed tumor regression in 85% of patients. Thus, the overall objective response rate was 59% (24/44) including 34% (n = 14) of complete remissions. This study mainly included Hodgkin lymphoma (n = 38) and anaplastic large cell lymphoma (n = 5). However, its efficacy in other types of NHL has never been reported although this study enrolled one patient with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
CD30 (TNFRSF8) is a transmembrane glycoprotein of the tumor necrosis factor receptor (TNFR) superfamily, and it is involved in signal transduction via the activation of the NF-κB pathway and the mitogen-activated protein kinases (MAPKs), ultimately modulating cell growth, proliferation and apoptosis. CD30 is a non-lineage-specific activation marker expressed by scattered B and T immunoblasts. In addition, a subset of cases in virtually all T-cell lymphoma entities may also express CD30 but at variable and generally lower levels. In fact, a recent study in 22 patients with extranodal NK/T-cell lymphoma showed 75% of positive rate of CD30 expression (75%). Moreover, CD30 expression was also documented in the tumor sample of EB virus positive diffuse large B-cell lymphomas (EBV + DLBCL) of the elderly (28.9%, 11/38). Therefore, Brentuximab vedotin may have potential benefits for patients with CD30-positive NHL other than anaplastic large cell lymphoma such as CD30-positive PTCLs, NOS. Considering the role of CD30 in signal transduction pathway associated with tumor growth and proliferation, its expression may be associated with tumor aggressiveness. In accordance with this, it is more likely that relapse or refractory NHLs may have CD30 expression, and the potential benefits of this promising agent as a salvage therapy deserve to be further investigated in these patients who have high risk of treatment failure. Thus, we designed a phase II study for relapsed or refractory NHL patients. This study is to explore the safety and activity of dosing once every 3 weeks of Brentuximab vedotin in patients with relapsed or refractory CD30-positive NHL other than anaplastic large cell lymphoma.
Read the detailed description
The principal investigator use a Simon two-stage minimax design based on overall response rates. Overall disease control rates will be calculated as the percent of patients that have confirmed complete response (CR) or partial response (PR) or stable disease (SD) by radiographic response including CT and/or PET scans. We assume a P0 as 20%, and designate a target rate (P1) as 40%. Under the error probabilities (α=0.05, β=0.20), eighteen patients will be enrolled in the first stage. If overall disease control rate is ≤ 4/18 in the first stage, this study will be stopped. If not, this study will recruit patients up to 33 considering 20% of drop out rate.
Intent-to-treat analysis will be applied to all primary and secondary efficacy endpoints. Response rate will be analyzed based on the response criteria according to Cheson 2007 (Cheson BD, et al. J Clin Oncol 2007; 25 (5):579-586), and data related to overall response rate will be analyzed by statistical analysis including Chi test to evaluate predictive factors for response to study drug.
Overall rate of disease control : CR, PR and SD Progression-free survival : Time between the date of treatment start and the date of death due to any cause or date of disease progression (Up to 36months) Data related to survival rate for all patients will be analyzed based on log-rank test by the Kaplan-Meier method.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Brentuximab vedotin
- Medical subject headings
- Lymphoma, Non-Hodgkin
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 must not be administered as an IV push or bolus. It must be administered in 100ml-250ml of 0.9% saline by intravenous infusion over 30 minutes once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab vedotin | Experimental | Brentuximab vedotin administered in 250ml of 0.9% saline by intravenous infusion over 30 minutes once every 3 weeks.
In the absence of infusion toxicities, the infusion rate for all patients must be calculated in order to achieve a 30-minute (approximate) infusion period.
Brentuximab Vedotin is dosed at 1.8mg/kg (capped at 100kg of body weight). Dosing is based on patients' weight according to the institutional standard; however, doses will be adjusted for patients who experience a ≥ 10% change in weight from baseline. Actual weight will be used except for patients weighing greater than 100 kg; dose will be calculated based on 100 kg for these individuals. The dose will be rounded to the nearest whole number of milligrams. Receives: Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall disease control rate
The percentage of subjects with complete response (CR) or partial response (PR) or stable disease (SD)
Measured: Until the disease progression (maximum 2 years after completion of treatment, assessed up to 36 months)
Secondary outcomes (3)
Progression-free survival (PFS)
Measured: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36months
Toxicity (assessed by analyzing adverse events and the standard clinical laboratory and hematologic findings.)
Toxicity will be assessed by analyzing adverse events and the standard clinical laboratory and hematologic findings.
Measured: From the date of first drug administration until the date of the 30th days, assessed up to 13 months
Overall survival (OS)
Measured: Time between the date of treatment start and the date of death due to any cause,assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Cheolwon Suh, M.D., Principal investigator, Asan Medical CenterJinSeok Kim, M.D., Principal investigator, Severance HospitalHyeonSeok Eom, M.D., Principal investigator, National Cancer Center of KoreaHyeJin Kang, M.D., Principal investigator, Korea Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280785
- Sponsor's protocol ID
- SMC 2014-04-059
- Acronym
- BRAN
- Status last verified
- Sep 2018
- First submitted
- 5 Oct 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Kim SJ, Yoon DH, Kim JS, Kang HJ, Lee HW, Eom HS, Hong JY, Cho J, Ko YH, Huh J, Yang WI, Park WS, Lee SS, Suh C, Kim WS. Efficacy of Brentuximab Vedotin in Relapsed or Refractory High-CD30-Expressing Non-Hodgkin Lymphomas: Results of a Multicenter, Open-Labeled Phase II Trial. Cancer Res Treat. 2020 Apr;52(2):374-387. doi: 10.4143/crt.2019.198. Epub 2019 Aug 13.
PubMed 31476851
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas Other Than Anaplastic Large Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02280785
- Acronym / sponsor ID
- BRAN / SMC 2014-04-059
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 3 Nov 2014 (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.
Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies (Clin Cancer Res. 2012) showed tumor regression in 85% of patients. Thus, the overall objective response rate was 59% (24/44) including 34% (n = 14) of complete remissions. This study mainly included Hodgkin lymphoma (n = 38) and anaplastic large cell lymphoma (n = 5). However, its efficacy in other types of NHL has never been reported although this study enrolled one patient with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
CD30 (TNFRSF8) is a transmembrane glycoprotein of the tumor necrosis factor receptor (TNFR) superfamily, and it is involved in signal transduction via the activation of the NF-κB pathway and the mitogen-activated protein kinases (MAPKs), ultimately modulating cell growth, proliferation and apoptosis. CD30 is a non-lineage-specific activation marker expressed by scattered B and T immunoblasts. In addition, a subset of cases in virtually all T-cell lymphoma entities may also express CD30 but at variable and generally lower levels. In fact, a recent study in 22 patients with extranodal NK/T-cell lymphoma showed 75% of positive rate of CD30 expression (75%). Moreover, CD30 expression was also documented in the tumor sample of EB virus positive diffuse large B-cell lymphomas (EBV + DLBCL) of the elderly (28.9%, 11/38). Therefore, Brentuximab vedotin may have potential benefits for patients with CD30-positive NHL other than anaplastic large cell lymphoma such as CD30-positive PTCLs, NOS. Considering the role of CD30 in signal transduction pathway associated with tumor growth and proliferation, its expression may be associated with tumor aggressiveness. In accordance with this, it is more likely that relapse or refractory NHLs may have CD30 expression, and the potential benefits of this promising agent as a salvage therapy deserve to be further investigated in these patients who have high risk of treatment failure. Thus, we designed a phase II study for relapsed or refractory NHL patients. This study is to explore the safety and activity of dosing once every 3 weeks of Brentuximab vedotin in patients with relapsed or refractory CD30-positive NHL other than anaplastic large cell lymphoma.
Detailed description
The principal investigator use a Simon two-stage minimax design based on overall response rates. Overall disease control rates will be calculated as the percent of patients that have confirmed complete response (CR) or partial response (PR) or stable disease (SD) by radiographic response including CT and/or PET scans. We assume a P0 as 20%, and designate a target rate (P1) as 40%. Under the error probabilities (α=0.05, β=0.20), eighteen patients will be enrolled in the first stage. If overall disease control rate is ≤ 4/18 in the first stage, this study will be stopped. If not, this study will recruit patients up to 33 considering 20% of drop out rate.
Intent-to-treat analysis will be applied to all primary and secondary efficacy endpoints. Response rate will be analyzed based on the response criteria according to Cheson 2007 (Cheson BD, et al. J Clin Oncol 2007; 25 (5):579-586), and data related to overall response rate will be analyzed by statistical analysis including Chi test to evaluate predictive factors for response to study drug.
Overall rate of disease control : CR, PR and SD Progression-free survival : Time between the date of treatment start and the date of death due to any cause or date of disease progression (Up to 36months) Data related to survival rate for all patients will be analyzed based on log-rank test by the Kaplan-Meier method.
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 administered in 250ml of 0.9% saline by intravenous infusion over 30 minutes once every 3 weeks. In the absence of infusion toxicities, the infusion rate for all patients must be calculated in order to achieve a 30-minute (approximate) infusion period. Brentuximab Vedotin is dosed at 1.8mg/kg (capped at 100kg of body weight). Dosing is based on patients' weight according to the institutional standard; however, doses will be adjusted for patients who experience a ≥ 10% change in weight from baseline. Actual weight will be used except for patients weighing greater than 100 kg; dose will be calculated based on 100 kg for these individuals. The dose will be rounded to the nearest whole number of milligrams. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically confirmed non-Hodgkin lymphomas with CD 30 expression. Criteria of positive CD30 expression are defined as in cases with membranous CD30 expression from more than 50% of neoplastic cells.
- Relapsed or progressed disease after two or more than two salvage chemotherapy
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Measurable disease > 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen/pelvis or CT/positron emission tomography (PET) scans
- Life expectancy of greater than 3 months
Key exclusion criteria (18 listed)
- Hodgkin lymphoma
- Anaplastic large cell lymphoma
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
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 must not be administered as an IV push or bolus. It must be administered in 100ml-250ml of 0.9% saline by intravenous infusion over 30 minutes once every 3 weeks. | Drug | Brentuximab vedotin |
Primary outcome
Overall disease control rate
Time frame: Until the disease progression (maximum 2 years after completion of treatment, assessed up to 36 months)
The percentage of subjects with complete response (CR) or partial response (PR) or stable disease (SD)
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36months
Toxicity (assessed by analyzing adverse events and the standard clinical laboratory and hematologic findings.)
Time frame: From the date of first drug administration until the date of the 30th days, assessed up to 13 months
Overall survival (OS)
Time frame: Time between the date of treatment start and the date of death due to any cause,assessed up to 36 months
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 6 Sep 2018.
- Derived from this study: PubMed 31476851Kim SJ, Yoon DH, Kim JS, Kang HJ, Lee HW, Eom HS, Hong JY, Cho J, Ko YH, Huh J, Yang WI, Park WS, Lee SS, Suh C, Kim WS. Efficacy of Brentuximab Vedotin in Relapsed or Refractory High-CD30-Expressing Non-Hodgkin Lymphomas: Results of a Multicenter, Open-Labeled Phase II Trial. Cancer Res Treat. 2020 Apr;52(2):374-387. doi: 10.4143/crt.2019.198. Epub 2019 Aug 13.
- Individual participant dataSharing planned: Yes
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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.
Cheolwon Suh, M.D. principal investigator
Asan Medical Center
JinSeok Kim, M.D. principal investigator
Severance Hospital
HyeonSeok Eom, M.D. principal investigator
National Cancer Center of Korea
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 in people with Non-Hodgkin Lymphoma, run by Samsung Medical Center at 4 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 17 inclusion and 18 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 6 Sep 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 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?
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 disease control rate (time frame: Until the disease progression (maximum 2 years after completion of treatment, assessed up to 36 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 NCT02280785, 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 6 Sep 2018.