Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma

Phase 1

Completed

• Conditions: Lymphoma, Non-Hodgkin
• Interventions: Drug: aflibercept

• Registration Number: NCT00644124
• Lead Sponsor: Sanofi

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 Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-26
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept RCHOP 14	aflibercept	Aflibercept (25 mg/ml by IV over an hour) in combination with fixed dose of rituximab (R), cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) administered every 2 weeks. A dose of 2.0 mg/kg administered as Dose Level 1, 4.0 mg/kg as Dose Level 2, and 6.0 mg/kg dose as Dose level 3.
Aflibercept RCHOP 21	aflibercept	Aflibercept (25 mg/ml by IV over an hour) in combination with fixed dose of rituximab (R), cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) administered every 3 weeks. A dose of 3.0 mg/kg administered as Dose Level 1, 6.0 mg/kg as Dose Level 2, and 8.0 mg/kg dose as Dose level 3.

Primary Outcome Measures

Name	Time	Method
selected dose of aflibercept based on Dose Limiting Toxicities observed	cycle 1 +/- 2

Secondary Outcome Measures

Name	Time	Method
Adverse events	treatment period
Response rate	cycle 2, 4 and 8
Progression free survival	study period
Biomarkers	Study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇫🇷 Paris, France