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Completed

NCT Number: NCT00644124

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

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.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Administrative Office

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

in combination with standard treatment R-CHOP

Primary outcomes

  1. selected dose of aflibercept based on Dose Limiting Toxicities observed

    Time frame: cycle 1 +/- 2

Secondary outcomes

  1. Adverse events

    Time frame: treatment period

  2. Response rate

    Time frame: cycle 2, 4 and 8

  3. Progression free survival

    Time frame: study period

  4. Biomarkers

    Time frame: Study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2008
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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