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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01040871 |
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Date of registration:
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29/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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A Randomized, Open-Label, Multicenter Phase 2 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 |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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164 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01040871 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Millennium Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patients 18 years or older.
- 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 treatment with VELCADE.
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diffuse Large B-Cell Lymphoma
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: Doxorubicin
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Drug: Prednisone
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Drug: Rituximab
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Drug: Vincristine
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Drug: VELCADE
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Primary Outcome(s)
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Complete Response (CR) Rate
[Time Frame: 6 cycles]
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Secondary Outcome(s)
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Change in Fatigue and Patient Utility Scores
[Time Frame: 18-24 months]
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Rate of Durable Response
[Time Frame: Median follow up approx. 12 months]
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Progression-free Survival (PFS)Rate at 1-year
[Time Frame: 1 year]
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Overall Survival Rate at 1-year
[Time Frame: 1 year]
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Subsequent Anti-lymphoma Therapy Rate at 1-year
[Time Frame: 1 year]
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Overall Response Rate
[Time Frame: 6 cycles]
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Rate of Durable Complete Response
[Time Frame: Median follow up approx 12 months]
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Secondary ID(s)
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26866138-LYM-2034
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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