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Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

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ClinicalTrials.gov Identifier: NCT00379574
Recruitment Status : Completed
First Posted : September 22, 2006
Results First Posted : March 14, 2013
Last Update Posted : March 15, 2013
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Cheolwon Suh, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma, Large-Cell, Diffuse Lymphoma, B-Cell Drug: Bortezomib Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisolone Drug: Lenograstim Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bortezomib + CHOP every 2 weeks
Bortezomib + CHOP(Cycloophosphamide, vincristine, doxorubicin,and predinisolone) every 2 weeks
 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 Name: velcade

Drug: Cyclophosphamide
cyclophosphamide 750mg/m2 day 1, every 2 weeks
Other Name: cytoxan

Drug: Doxorubicin
doxorubicin 50 mg/m2 day 1, every 2 weeks
Other Name: adriamycin

Drug: Vincristine
vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks
Other Name: Oncovin

Drug: Prednisolone
prednisolone 100 mg days 1-5, every 2 weeks
Other Name: Pd

Drug: Lenograstim
Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
Other Names:
  • Neutrogin
  • G-CSF


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Patients Who Experienced Adverse Events [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379574


Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Asan Medical Cener
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Janssen Korea, Ltd., Korea
Investigators
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Principal Investigator: Cheolwon Suh, M.D.,Ph.D. Asan Medical Center
More Information
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Responsible Party: Cheolwon Suh, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00379574    
Other Study ID Numbers: AMC 2006-276
First Posted: September 22, 2006    Key Record Dates
Results First Posted: March 14, 2013
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by Cheolwon Suh, Asan Medical Center:
diffuse large B-cell lymphoma
Bortezomib
CHOP
Lenograstim
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisolone
Cyclophosphamide
Doxorubicin
Vincristine
Bortezomib
 Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic