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

NCT ID: NCT00644124

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-10-31

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.

Conditions

Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aflibercept RCHOP 14

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.

Group Type: EXPERIMENTAL

aflibercept

Intervention Type: DRUG

in combination with standard treatment R-CHOP

Aflibercept RCHOP 21

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.

Group Type: EXPERIMENTAL

aflibercept

Intervention Type: DRUG

in combination with standard treatment R-CHOP

Interventions

aflibercept

in combination with standard treatment R-CHOP

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne Haioun, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etudes du Lymphome de l'Adulte

Locations

Sanofi-Aventis Administrative Office

Paris, , France

Countries

France

Other Identifiers

EudraCT 2007-003737-16

Identifier Type: -

Identifier Source: secondary_id

TCD10173

Identifier Type: -

Identifier Source: org_study_id