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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644124

TCD10173

EudraCT 2007-003737-16

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Aflibercept RCHOP 14

Experimental group

Description:

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.

Treatment:

Drug: aflibercept

Aflibercept RCHOP 21

Experimental group

Description:

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.

Treatment:

Drug: aflibercept