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Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

Primary Purpose

Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bortezomib
Cyclophosphamide
Doxorubicin
Vincristine
Prednisolone
Lenograstim
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large-Cell, Diffuse focused on measuring diffuse large B-cell lymphoma, Bortezomib, CHOP, Lenograstim

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center, University of Ulsan College of Medicine
  • Asan Medical Cener

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib + CHOP every 2 weeks

Arm Description

Bortezomib + CHOP(Cycloophosphamide, vincristine, doxorubicin,and predinisolone) every 2 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients Who Experienced Adverse Events

Full Information

First Posted
September 21, 2006
Last Updated
March 13, 2013
Sponsor
Asan Medical Center
Collaborators
Janssen Korea, Ltd., Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00379574
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Janssen Korea, Ltd., Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell
Keywords
diffuse large B-cell lymphoma, Bortezomib, CHOP, Lenograstim

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bortezomib + CHOP every 2 weeks
Arm Type
Experimental
Arm Description
Bortezomib + CHOP(Cycloophosphamide, vincristine, doxorubicin,and predinisolone) every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
cytoxan
Intervention Description
cyclophosphamide 750mg/m2 day 1, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
adriamycin
Intervention Description
doxorubicin 50 mg/m2 day 1, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Pd
Intervention Description
prednisolone 100 mg days 1-5, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Lenograstim
Other Intervention Name(s)
Neutrogin, G-CSF
Intervention Description
Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
Primary Outcome Measure Information:
Title
Number of Patients Who Achieved Complete Response
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Who Experienced Adverse Events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolwon Suh, M.D.,Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Asan Medical Cener
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

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