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

This study has been completed.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 21, 2008
Last updated: May 5, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: aflibercept
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • selected dose of aflibercept based on Dose Limiting Toxicities observed [ Time Frame: cycle 1 +/- 2 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: treatment period ]
  • Response rate [ Time Frame: cycle 2, 4 and 8 ]
  • Progression free survival [ Time Frame: study period ]
  • Biomarkers [ Time Frame: Study period ]

Enrollment: 25
Study Start Date: March 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: aflibercept
in combination with standard treatment R-CHOP
Experimental: 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.
Drug: aflibercept
in combination with standard treatment R-CHOP


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00644124

Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Regeneron Pharmaceuticals
Principal Investigator: Corinne Haioun, MD Groupe d'Etudes du Lymphome de l'Adulte
  More Information

Additional Information:
Responsible Party: Sanofi Identifier: NCT00644124     History of Changes
Other Study ID Numbers: TCD10173
EudraCT 2007-003737-16
Study First Received: March 21, 2008
Last Updated: May 5, 2016

Keywords provided by Sanofi:
Non-Hodgkin's lymphoma
angiogenesis inhibitors
CHOP protocol

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on May 25, 2017