Lymphoma, Non-Hodgkin
Conditions
Keywords
Non-Hodgkin's lymphoma, angiogenesis inhibitors, CHOP protocol
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.
Interventions
DRUGaflibercept
in combination with standard treatment R-CHOP
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| selected dose of aflibercept based on Dose Limiting Toxicities observed | cycle 1 +/- 2 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | treatment period |
| Response rate | cycle 2, 4 and 8 |
| Progression free survival | study period |
| Biomarkers | Study period |
Countries
France
Outcome results
None listed