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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644124
• Other study ID #: TCD10173
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2008
• Last updated: May 5, 2016
• Start date: March 2008
• Est. completion date: October 2011

Study information

• Verified date: May 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• aflibercept
in combination with standard treatment R-CHOP

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	selected dose of aflibercept based on Dose Limiting Toxicities observed		cycle 1 +/- 2	Yes
Secondary	Adverse events		treatment period	Yes
Secondary	Response rate		cycle 2, 4 and 8	No
Secondary	Progression free survival		study period	No
Secondary	Biomarkers		Study period	No

External Links

•   ASCO annual meeting website to abstract