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

Sponsor
Sanofi
Study ID
NCT00644124
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept — DRUG
    in combination with standard treatment R-CHOP

Study Details

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.

Key Dates

Start date
Mar 31, 2008
Status verified
May 2016
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

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