A Trial of Bevacizumab in Myelodysplastic Syndromes (Int-1, Int-2 and High Risk According to International Prognostic Scoring System (IPSS)) With Excess of Marrow Blasts

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT00565656
Phase
PHASE2
Status
Terminated

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

First listed
Nov 30, 2007
Start date
Jul 31, 2007
Status verified
Jun 2009
Primary completion
Jul 31, 2009
Completion
Jul 31, 2010

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Bevacizumab

Primary Outcome Measure

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 ]

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