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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:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00644124
First received: March 21, 2008
Last updated: January 3, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: cycle 2, 4 and 8 ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: study period ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Study period ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: March 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aflibercept
    in combination with standard treatment R-CHOP
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00644124     History of Changes
Other Study ID Numbers: TCD10173, EudraCT 2007-003737-16
Study First Received: March 21, 2008
Last Updated: January 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 20, 2014