Diffuse Large B Cell LymphomaPhase 2BormaNCT01965977
Bortezomib Maintenance in High Risk DLBCL
A Phase 2 study testing Bortezomib in people with Diffuse Large B Cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival (OS), 3 years event free survival… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2015to 30 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly histologically confirmed CD20 positive diffuse large B-cell lymphomas and only Non-GCB type will be included
- High intermediate or high risk by IPI risk, or Bulky mass ≥ 10cm at diagnosis
- Complete response is confirmed after six or eight cycles R-CHOP chemotherapy by CT scan with confirmed negative PET-CT based on the Revised International Workshop Criteria.
- Additional surgery or radiotherapy are accepted
- Age ≥ 20
- Performance status (ECOG) ≤ 2
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- Adeqaute renal function: Cr < 2.5 mg/dL
- Adeqaute liver functions: Transaminase (AST/ALT) < 3 x upper normal value UNV)Bilirubin < 1.5 x UNV Alkaline phosphatase < 5 xUNV
- Adeqaute BM functions: ANC > 1,000/uL and platelet > 75,000/uL and hemoglobin > 9.0 g/dL
- Written Informed consent
Who cannot join
- Tumor response after 6-8 cycles CTx< CR
- Consider stem cell transplantation
- Central nervous system (CNS) metastases
- Pregnant or lactating women, patients of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions A. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection
- Any other malignancies within the past 5 years except curatively treated non- melanoma skin cancer or in situ carcinoma of cervix uteri.
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- Prior history of allegic reaction to study treatment drugs
- Peripheral neuropathy grade 2 or worse
- DLBCL of the testis and primary mediastinal DLBCL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Multicenter Phase II Study of Bortezomib for Maintenance Therapy in Patients With High Risk Diffuse Large B Cell Lymphoma
This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT\&GOG-Ntx)
Read the detailed description
High-intermediate or high risk in IPI has a long-term chance of cure in the range about 50% in patients with DLBCL treated by R-CHOP. These high risk patients should be considered for additional new treatment to standard R-CHOP or investigational approaches in the context of clinical trials that are designed to ensure that potentially curative therapy.
Bortezomib has shown activity in vitro against DLBCL-derived cell lines. Single-agent bortezomib or chemotherapy combined bortezomib are feasible in follicular, mantle cell, marginal zone lymphoma and DLBCL with manageable toxicities. Bortezomib enhances the activity of chemotherapy in non-GCB but not GCB DLBCL, and provide a rational therapeutic approach based on genetically distinct DLBCL subtypes.
High CR/CRu rate with bortezomib with standard R-CHOP suggests it may be a good backbone for additional maintenance leading to durable response. However, there is no study of bortezomib as maintenance therapy after treated with R-CHOP in high risk patients with DLBCL. So we applied additional bortezomib as maintenance therapy in order to assess improving efficacy and survival rates in high risk patients with non-GCB DLBCL who had been confirmed CR after treated with R-CHOP.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Bortezomib
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called velcade
Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | bortezomib 1.3mg/m2 subcutaneous on day 1 and15 Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
3years relapse free survival
3years relapse free survival will be assessed after starting maintenance therapy for 1year and then following up for 3years.
Measured: from the date of first drug administration until the date of last follow up, assessed up to 4years
Secondary outcomes (4)
3years overall survival
3years overall survival will be assessed after starting maintenance therapy for 1year and then following up for 3years.
Measured: from the date of first drug administration until the date of last follow up, assessed up to 4years
3years event free survival
3years event free survival will be assessed after starting maintenance therapy for 1year and then following up for 3years.
Measured: from the date of first drug administration until the date of last follow up, assessed up to 4years
Toxicity profiles
Safety profiles will be evaluated using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: from the date of first drug administration until the date of the 30th day after last cycle of chemotherapy
Quality of life scale
Quality of life will be assessed after starting maintenance therapy for 1year and then following up for 3years by using FACT\&GOG-Ntx.
Measured: from the date of first drug administration until the date of last follow up, assessed up to 4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study start8 Apr 2015
- Primary completion30 Oct 2018
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Wonseog Kim, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965977
- Sponsor's protocol ID
- SMC2013-04-124
- Acronym
- Borma
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2013
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter Phase II Study of Bortezomib for Maintenance Therapy in Patients With High Risk Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01965977
- Acronym / sponsor ID
- Borma / SMC2013-04-124
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 18 Oct 2013 (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 study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT\&GOG-Ntx)
Detailed description
High-intermediate or high risk in IPI has a long-term chance of cure in the range about 50% in patients with DLBCL treated by R-CHOP. These high risk patients should be considered for additional new treatment to standard R-CHOP or investigational approaches in the context of clinical trials that are designed to ensure that potentially curative therapy.
Bortezomib has shown activity in vitro against DLBCL-derived cell lines. Single-agent bortezomib or chemotherapy combined bortezomib are feasible in follicular, mantle cell, marginal zone lymphoma and DLBCL with manageable toxicities. Bortezomib enhances the activity of chemotherapy in non-GCB but not GCB DLBCL, and provide a rational therapeutic approach based on genetically distinct DLBCL subtypes.
High CR/CRu rate with bortezomib with standard R-CHOP suggests it may be a good backbone for additional maintenance leading to durable response. However, there is no study of bortezomib as maintenance therapy after treated with R-CHOP in high risk patients with DLBCL. So we applied additional bortezomib as maintenance therapy in order to assess improving efficacy and survival rates in high risk patients with non-GCB DLBCL who had been confirmed CR after treated with R-CHOP.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: Bortezomibbortezomib 1.3mg/m2 subcutaneous on day 1 and15 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly histologically confirmed CD20 positive diffuse large B-cell lymphomas and only Non-GCB type will be included
- High intermediate or high risk by IPI risk, or Bulky mass ≥ 10cm at diagnosis
- Complete response is confirmed after six or eight cycles R-CHOP chemotherapy by CT scan with confirmed negative PET-CT based on the Revised International Workshop Criteria.
- Additional surgery or radiotherapy are accepted
- Age ≥ 20
Key exclusion criteria (9 listed)
- Tumor response after 6-8 cycles CTx< CR
- Consider stem cell transplantation
- Central nervous system (CNS) metastases
- Pregnant or lactating women, patients of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions A. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection
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 |
|---|---|---|
| BortezomibAlso: velcadeBortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months | Drug | Bortezomib |
Primary outcome
3years relapse free survival
Time frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
3years relapse free survival will be assessed after starting maintenance therapy for 1year and then following up for 3years.
4 secondary outcomes
3years overall survival
Time frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
3years event free survival
Time frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
Toxicity profiles
Time frame: from the date of first drug administration until the date of the 30th day after last cycle of chemotherapy
Quality of life scale
Time frame: from the date of first drug administration until the date of last follow up, assessed up to 4years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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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.
Wonseog Kim, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib in people with Diffuse Large B Cell 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. 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.
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?
Results are not available in the source record.
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?
3years relapse free survival (time frame: from the date of first drug administration until the date of last follow up, assessed up to 4years). 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 23 Oct 2020; AzTrials last refreshed its copy on 3 Nov 2026.