Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Lymphoma, Large-Cell, Diffuse Lymphoma, B-Cell |
| Intervention | Drug: Bortezomib Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisolone Drug: Lenograstim |
| Phase | Phase 1/Phase 2 |
| Sponsor | Asan Medical Center |
| Responsible Party | Asan Medical Center |
| ClinicalTrials.gov Identifier | NCT00379574 |
| First Received | September 21, 2006 |
| Last Updated | March 13, 2013 |
| Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 21, 2006 |
|---|---|
| Last Updated Date | March 13, 2013 |
| Start Date | September 2006 |
| Estimated Primary Completion Date | January 2011 |
| Current Primary Outcome Measures | Number of Patients Who Achieved Complete Response [Time Frame: 14 weeks] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | Number of Patients Who Experienced Adverse Events [Time Frame: 6 months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL |
|---|---|
| Official Title | A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas |
| Brief 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. 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 Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Bortezomib 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. Other Names: velcadeDrug: Cyclophosphamide cyclophosphamide 750mg/m2 day 1, every 2 weeks Other Names: cytoxanDrug: Doxorubicin doxorubicin 50 mg/m2 day 1, every 2 weeks Other Names: adriamycinDrug: Vincristine vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks Other Names: OncovinDrug: Prednisolone prednisolone 100 mg days 1-5, every 2 weeks Other Names: PdDrug: Lenograstim Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks Other Names:
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| Study Arm (s) | Experimental: Bortezomib + CHOP every 2 weeks Bortezomib + CHOP(Cycloophosphamide, vincristine, doxorubicin,and predinisolone) every 2 weeks |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 49 |
| Estimated Completion Date | January 2011 |
| Estimated Primary Completion Date | January 2011 |
| Eligibility Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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 |
| Gender | Both |
| Ages | 15 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00379574 |
|---|---|
| Other Study ID Numbers | AMC 2006-276 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Asan Medical Center |
| Study Sponsor | Asan Medical Center |
| Collaborators | Janssen Korea, Ltd., Korea |
| Investigators | Principal Investigator: Cheolwon Suh, M.D.,Ph.D. Asan Medical Center |
| Verification Date | March 2013 |
Locations[ + expand ][ + ]
| Asan Medical Cener | Seoul, Korea, Republic of |
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| Asan Medical Center, University of Ulsan College of Medicine | Seoul, Korea, Republic of, 138-736 |