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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644124
First Posted: March 26, 2008
Last Update Posted: May 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644124


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00644124     History of Changes
Other Study ID Numbers: TCD10173
EudraCT 2007-003737-16
First Submitted: March 21, 2008
First Posted: March 26, 2008
Last Update Posted: May 6, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases