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

Phase 2
60 Years
Not Enrolling
Myelodysplastic Syndromes

Thank you

Trial Information

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

Inclusion Criteria:

- MDS patient with excess of marrow blasts (≥ 5%) including RAEB, RAEB-t and CMML with
leucocytes < 10 000/mm3 according to FAB classification

- IPSS int-1, int-2 or high

- Age > 60 years (younger adults may be included, but only in the absence of donor for
allogeneic stem cell transplantation, and if contra-indication to intensive

- No previous allogeneic SCT or intensive anthracycline-Ara C chemotherapy.

- Adequate renal function:

- Serum creatinine ≤ 1.25 x ULN or calculated creatinine clearance ≥ 50 mL/min AND

- Urine dipstick for proteinuria < 2+. Patients discovered to have ≥ 2+
proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine
collection and must demonstrate ≤ 1 g of protein in 24 hours

- Adequate liver function:

- Total bilirubin < 1.5 x upper limit of normal (ULN) AND Asparagine
aminotransferase (AST), alanine aminotransferase (ALT) < 2.5 x ULN in patients
without liver metastases

- International normalised ratio (INR) ≤1.5 and prothrombin time (PPT) ≤ 1.5 x ULN
within 7 days prior to enrolment

- If female, should not be pregnant or breast-feeding. Women with an intact uterus
(unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy
test within 28 days prior to enrollment into the study. If a serum pregnancy test is
not performed within 7 days prior to the first dose of bevacizumab, a confirmatory
urine test (within 7 days prior to the first dose of bevacizumab) is required.

- Life expectancy ≥ 6 months

- Patient with health insurance

- Written informed consent

Exclusion Criteria:

- Therapy related MDS (after chemo or radiotherapy) for a previous neoplasm or other
disease including AML

- A preexisting thrombocytopenia < 20 000/mm3

- Major surgery (including open biopsy), significant traumatic injury within 28 days
prior to enrolment or anticipation of the need for major surgery during study

- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior
to the first bevacizumab infusion

- Prior tumor (except localized cervix carcinoma or cutaneous basal cell carcinoma)
unless in remission for at least 3 years.

- Uncontrolled diabetes mellitus

- Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325

- Uncontrolled hypertension (blood pressures: systolic > 150 mmHg and/or diastolic >
100 mmHg)

- Clinically significant (i.e., active) cardiovascular disease for example CVA (≤6
months before enrollment), myocardial infarction (≤ 6 months before enrollment),
unstable angina, congestive heart failure NYHA Class ≥ II, serious cardiac arrhythmia
requiring medication during the study and might interfere with regularity of the
study treatment, or not controlled by medication

- Non-healing wound, active peptic ulcer or bone fracture

- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months of enrolment

- Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using
effective, non-hormonal means of contraception (intrauterine contraceptive device,
barrier method of contraception in conjunction with spermicidal jelly or surgically
sterile) during the study and for a period of 6 months following the last
administration of bevacizumab. Men who do not agree to use effective contraception
during the study and for a period of 60 days following the last administration of

- Investigational treatment for MDS within 6 weeks of treatment onset

- Patients unable to give informed consent or to be followed up adequately

- Known hypersensitivity to a product from Chinese Hamster Ovary mammalian cell or to a
recombinant humanized monoclonal antibody

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Bone marrow evaluation Peripheral blood evaluation Cytogenetic response Hematologic improvement (HI)

Outcome Time Frame:

Before the first injection, weekly during twenty weeks and four weeks after the last injection

Safety Issue:


Principal Investigator

Laurence LEGROS, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nice


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

July 2007

Completion Date:

July 2010

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic syndromes (int-1, int-2 and high risk according to IPSS) with excess of marrow blasts including CMML with leucocytes<10 000/mm3
  • Myelodysplastic Syndromes
  • Preleukemia