Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
NCT ID: NCT01040871
Last Updated: 2014-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2010-01-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VR-CAP
VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
VELCADE
VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.
Rituximab
Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Cyclophosphamide
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Prednisone
Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
R-CHOP
R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
Rituximab
Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Cyclophosphamide
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Prednisone
Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Interventions
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VELCADE
VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.
Rituximab
Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Cyclophosphamide
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Doxorubicin
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Prednisone
Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Vincristine
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).
* At least 1 measurable site of disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
* Male subjects must agree to use a double barrier method of birth control
Exclusion Criteria
* Prior extended radiotherapy or chemotherapy for lymphoma
* More than 150 mg/m2 of prior doxorubicin
* Major surgery within 3 weeks of study.
* Peripheral neuropathy or neuralgia of Grade 2 or worse.
* Active CNS lymphoma
* Diagnosed or treated for a malignancy other than NHL, with some exceptions
* Pregnant or breast feeding
* Active systemic infection
* Documented of suspected human immunodeficiency virus (HIV)/AIDS
* Uncontrolled or severe cardiovascular disease
* Known allergies, hypersensitivity or intolerance to study drugs
* Serious medical condition that could interfere with study
* Concurrent treatment with another investigational agent
18 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie
Ghent, , Belgium
Countries
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References
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Offner F, Samoilova O, Osmanov E, Eom HS, Topp MS, Raposo J, Pavlov V, Ricci D, Chaturvedi S, Zhu E, van de Velde H, Enny C, Rizo A, Ferhanoglu B. Frontline rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib (VR-CAP) or vincristine (R-CHOP) for non-GCB DLBCL. Blood. 2015 Oct 15;126(16):1893-901. doi: 10.1182/blood-2015-03-632430. Epub 2015 Jul 31.
Other Identifiers
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26866138-LYM-2034
Identifier Type: -
Identifier Source: org_study_id
NCT01826084
Identifier Type: -
Identifier Source: nct_alias
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