Phase 2
N=49
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
Lymphoma, Large-Cell, Diffuse · Lymphoma, B-Cell
Bottom Line
View on ClinicalTrials.gov: NCT00379574 ↗Enrolled (actual)
49
Serious AEs
44.9%
Results posted
Mar 2013
Primary outcome: Primary: Number of Patients Who Achieved Complete Response — 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Prednisolone (Drug); Lenograstim (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieved Complete Response |
32 | — |
| SECONDARY Number of Patients Who Experienced Adverse Events |
49 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00379574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.