The objectives of this phase II trial are to test the efficacy and tolerance of Bevacizumab in MDS patients with excess of marrow blasts and to evaluate the impact of Bevacizumab on angiogenesis and erythropoiesis. To limit the myelotoxicity observed in the preliminary phase II study, Bevacizumab will be administrated at the initial dose of 5 mg/kg. The primary endpoint will be response: Complete Remission (CR), Partial Remission (PR) and hematological improvement (HI) according to IWG criteria (see appendix 3). The secondary endpoints will be survival, response duration, side effects, evaluation of angiogenesis (bone marrow microvessel density, VEGF plasma level, VEGF mRNA expression, HIF-1alpha expression). The design of this study consists of three study periods: pre-treatment (screening), treatment (loading and maintenance), and follow-up. All patients will participate in the study for at least 12 weeks of therapy, a 4-week follow-up visit, and long-term follow-up unless the criteria for planned or unplanned early discontinuation are met.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administration of Bevacizumab
Department of clinical hematology
Avignon, France
Department of Hematology
Bobigny, France
Department of Hematology
Lyon, France
Paoli-Calmette Institut
Marseille, France
Department of Clinical hematology, Archet Hospital, CHU de Nice
Nice, France
Department of Onco-Hematology, Caremeau Hospital, CHU Nîmes
Nîmes, France
Department of clinical hematology, Robert Debré Hospital
Reims, France
Department of Hematology and Oncology, CHU de Strasbourg
Strasbourg, France
Service de Médecine Interne
Toulouse, France
Department of clinical hematology
Vandœuvre-lès-Nancy, France
Bone marrow evaluation Peripheral blood evaluation Cytogenetic response Hematologic improvement (HI)
Time frame: Before the first injection, weekly during twenty weeks and four weeks after the last injection
The secondary endpoints will be survival, side effects
Time frame: weekly
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