Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL

NCT00379574 | Completed Phase 1 Results DMC

• 1 other identifier: AMC 2006-276
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

diffuse large B-cell lymphoma; Bortezomib; CHOP; Lenograstim

Outcome Measures

Primary Outcomes (1)

• 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.

  14 weeks

Secondary Outcomes (1)

• Number of Patients Who Experienced Adverse Events

  6 months

Study Arms (1)

Bortezomib + CHOP every 2 weeks

EXPERIMENTAL

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

Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone; Drug: Lenograstim

Interventions

Bortezomib DRUG

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.

Also known as: velcade

Bortezomib + CHOP every 2 weeks

Cyclophosphamide DRUG

cyclophosphamide 750mg/m2 day 1, every 2 weeks

Also known as: cytoxan

Bortezomib + CHOP every 2 weeks

Doxorubicin DRUG

doxorubicin 50 mg/m2 day 1, every 2 weeks

Also known as: adriamycin

Bortezomib + CHOP every 2 weeks

Vincristine DRUG

vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks

Also known as: Oncovin

Bortezomib + CHOP every 2 weeks

Prednisolone DRUG

prednisolone 100 mg days 1-5, every 2 weeks

Also known as: Pd

Bortezomib + CHOP every 2 weeks

Lenograstim DRUG

Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks

Also known as: Neutrogin, G-CSF

Bortezomib + CHOP every 2 weeks

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Janssen Korea, Ltd., Korea: collaborator

Study Sites (2)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Asan Medical Cener

Seoul, South Korea

Location

MeSH Terms

Conditions

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

Interventions

Bortezomib; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone; Lenograstim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Cheolwon Suh
• Organization: Asan Medical Center, Ulsan University College of Medicine

csuh@amc.seoul.kr

+82-2-3010-3209

Study Officials

• Cheolwon Suh, M.D.,Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 15, 2013
• Results First Posted: March 14, 2013

Record last verified: 2013-03

Locations

KR (2)