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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
aflibercept
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Non-Hodgkin's lymphoma, angiogenesis inhibitors, CHOP protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aflibercept RCHOP 14

Aflibercept RCHOP 21

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

selected dose of aflibercept based on Dose Limiting Toxicities observed

Secondary Outcome Measures

Adverse events
Response rate
Progression free survival
Biomarkers

Full Information

First Posted
March 21, 2008
Last Updated
May 5, 2016
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00644124
Brief Title
Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Non-Hodgkin's lymphoma, angiogenesis inhibitors, CHOP protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept RCHOP 14
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept RCHOP 21
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
aflibercept
Intervention Description
in combination with standard treatment R-CHOP
Primary Outcome Measure Information:
Title
selected dose of aflibercept based on Dose Limiting Toxicities observed
Time Frame
cycle 1 +/- 2
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
treatment period
Title
Response rate
Time Frame
cycle 2, 4 and 8
Title
Progression free survival
Time Frame
study period
Title
Biomarkers
Time Frame
Study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Haioun, MD
Organizational Affiliation
Groupe d'Etudes du Lymphome de l'Adulte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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