Lymphoma, Large-Cell, DiffusePhase 1/2NCT00379574
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
A Phase 1/2 study testing Bortezomib, Cyclophosphamide and Doxorubicin in people with Lymphoma, Large-Cell, Diffuse and Lymphoma, B-Cell, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the clinical results have been improved with new drugs and new modalities such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell
- What is being tested?
- Bortezomib, Cyclophosphamide and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2006to Jan 2011
- Phase
- Phase 1/2
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed DLBCL
- Age 70 years or less
- Previously untreated
- Performance status: ECOG 0-2
- Advanced stage: stage III, IV, or non-contiguous stage II
- Measurable disease: 1 cm or more by spiral CT
- Normal liver function
Who cannot join
- Platelet count less than 75,000/microL within 14 days before enrollment.
- Absolute neutrophil count of less than 1,500/microlL within 14 days before enrollment.
- Cr more than 2.0 mg/dL and/or calculated or measured creatinine clearance less than 50 mL/min within 14 days before enrollment.
- Peripheral neuropathy of Grade 2 or worse within 14 days before enrollment.
- Hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding.
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- Other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
Asan Medical Cener
Seoul
About this study
Official title: A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas
Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the clinical results have been improved with new drugs and new modalities such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib is well known to be effective for multiple myeloma and has been being tried for other malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every 2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.
Read the detailed description
Intended number of patients: 63 patients in total
- Phase I: 9 patients for 3 levels
- Phase II: 50 patients plus 3 patient from Phase I at MTD level
- Plus 4 patients: considering 5% follow-up loss rate
Study design and methodology:
For phase I, 9 patients; 3 levels of bortezomib (1.0, 1.3 and 1.6 mg/m2), 3 patients at each dose level.
If escalation of bortezomib beyond 1.0 mg/m2 is not possible, the trial will be stopped.
For phase II, 53 patients (3 from phase I at MTD level); Reject when complete response rate equal or less than 12/19 or 37/53 by Simon two-stage optimal phase II design.
Treatments:
- Bortezomib:
For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.
For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.
- CHOP2: cyclophosphamide 750mg/ m2 day 1, vincristine 1.4 mg/ m2 (max. 2 mg) day 1, doxorubicin 50 mg/ m2 day 1, prednisolone 100 mg days 1-5, every 2 weeks.
- G-CSF: Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks.
- Conditions
- Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell
- Being tested
- Bortezomib, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone
- Keywords
- diffuse large B-cell lymphoma, Bortezomib, CHOP, Lenograstim
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called velcade
Bortezomib:
For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.
For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.
CyclophosphamideDrug
Also called cytoxan
cyclophosphamide 750mg/m2 day 1, every 2 weeks
DoxorubicinDrug
Also called adriamycin
doxorubicin 50 mg/m2 day 1, every 2 weeks
VincristineDrug
Also called Oncovin
vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
PrednisoloneDrug
Also called Pd
prednisolone 100 mg days 1-5, every 2 weeks
LenograstimDrug
Also called Neutrogin, G-CSF
Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib + CHOP every 2 weeks | Experimental | Bortezomib + CHOP(Cycloophosphamide, vincristine, doxorubicin,and predinisolone) every 2 weeks Receives: Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone; Drug: Lenograstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Achieved Complete Response
All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.
Measured: 14 weeks
Secondary outcomes (1)
Number of Patients Who Experienced Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2011
- Study completionJan 2011
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.
- Other trials for Lymphoma, Large-Cell, DiffuseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Principal investigator, Cheolwon Suh, Asan Medical Center
- Investigators
- Cheolwon Suh, M.D.,Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379574
- Sponsor's protocol ID
- AMC 2006-276
- Status last verified
- Mar 2013
- First submitted
- 21 Sep 2006
- Last updated
- 15 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT00379574
- Acronym / sponsor ID
- AMC 2006-276
- Conditions
- Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell
- Keywords
- diffuse large B-cell lymphoma, Bortezomib, CHOP, Lenograstim
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Sep 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Sep 2006 (estimated)
- Results
- Posted 14 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the clinical results have been improved with new drugs and new modalities such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib is well known to be effective for multiple myeloma and has been being tried for other malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every 2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.
Detailed description
Intended number of patients: 63 patients in total
- Phase I: 9 patients for 3 levels
- Phase II: 50 patients plus 3 patient from Phase I at MTD level
- Plus 4 patients: considering 5% follow-up loss rate
Study design and methodology:
For phase I, 9 patients; 3 levels of bortezomib (1.0, 1.3 and 1.6 mg/m2), 3 patients at each dose level.
If escalation of bortezomib beyond 1.0 mg/m2 is not possible, the trial will be stopped.
For phase II, 53 patients (3 from phase I at MTD level); Reject when complete response rate equal or less than 12/19 or 37/53 by Simon two-stage optimal phase II design.
Treatments:
- Bortezomib:
For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.
For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.
- CHOP2: cyclophosphamide 750mg/ m2 day 1, vincristine 1.4 mg/ m2 (max. 2 mg) day 1, doxorubicin 50 mg/ m2 day 1, prednisolone 100 mg days 1-5, every 2 weeks.
- G-CSF: Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib + CHOP every 2 weeks | Experimental | Drug: Bortezomib, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisolone, Drug: LenograstimBortezomib + CHOP(Cycloophosphamide, vincristine, doxorubicin,and predinisolone) every 2 weeks |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed DLBCL
- Age 70 years or less
- Previously untreated
- Performance status: ECOG 0-2
- Advanced stage: stage III, IV, or non-contiguous stage II
Key exclusion criteria (9 listed)
- Platelet count less than 75,000/microL within 14 days before enrollment.
- Absolute neutrophil count of less than 1,500/microlL within 14 days before enrollment.
- Cr more than 2.0 mg/dL and/or calculated or measured creatinine clearance less than 50 mL/min within 14 days before enrollment.
- Peripheral neuropathy of Grade 2 or worse within 14 days before enrollment.
- Hypersensitivity to bortezomib, boron or mannitol.
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: For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks. For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks. | Drug | Bortezomib + CHOP every 2 weeks |
| CyclophosphamideAlso: cytoxancyclophosphamide 750mg/m2 day 1, every 2 weeks | Drug | Bortezomib + CHOP every 2 weeks |
| DoxorubicinAlso: adriamycindoxorubicin 50 mg/m2 day 1, every 2 weeks | Drug | Bortezomib + CHOP every 2 weeks |
| VincristineAlso: Oncovinvincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks | Drug | Bortezomib + CHOP every 2 weeks |
| PrednisoloneAlso: Pdprednisolone 100 mg days 1-5, every 2 weeks | Drug | Bortezomib + CHOP every 2 weeks |
| LenograstimAlso: Neutrogin, G-CSFLenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks | Drug | Bortezomib + CHOP every 2 weeks |
Primary outcome
Number of Patients Who Achieved Complete Response
Time frame: 14 weeks
All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.
1 secondary outcome
Number of Patients Who Experienced Adverse Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.,Ph.D. principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bortezomib, Cyclophosphamide and Doxorubicin in people with Lymphoma, Large-Cell, Diffuse and Lymphoma, B-Cell, run by Asan Medical Center at 2 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 7 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: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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 14 Mar 2013). 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?
Number of Patients Who Achieved Complete Response (time frame: 14 weeks). 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 15 Mar 2013; AzTrials last refreshed its copy on 26 Oct 2026.