Status:
COMPLETED
Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Meth...
Eligibility Criteria
Inclusion
- Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated
Exclusion
- Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
- Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
- Cerebral or leptomeningeal involvement.
- History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for \> 5 years are allowed)
- Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
- Any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Abnormal kidney function
- Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
- Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
- History of hypersensitivity to any Trap agents or recombinant proteins
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00644124
Start Date
March 1 2008
End Date
October 1 2011
Last Update
May 6 2016
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Paris, France