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Myelodysplastic SyndromesPhase 2NCT00565656

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

A Phase 2 study testing BEVACIZUMAB in people with Myelodysplastic Syndromes, run by Centre Hospitalier Universitaire de Nice at 10 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
BEVACIZUMAB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesFrance
Study dates
Jul 2007to Jul 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 chemotherapy)
  • 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
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  • 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

Who cannot join

  • 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 treatment
  • 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
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  • Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day)
  • 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 bevacizumab
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Department of clinical hematology

    Avignon

  • Department of Hematology

    Bobigny, 93009

  • Department of Hematology

    Lyon, 69437

  • Paoli-Calmette Institut

    Marseille, 13009

  • Department of Clinical hematology, Archet Hospital, CHU de Nice

    Nice, 06000

  • Department of Onco-Hematology, Caremeau Hospital, CHU Nîmes

    Nîmes, 30029

  • Department of clinical hematology, Robert Debré Hospital

    Reims, 51092

  • Department of Hematology and Oncology, CHU de Strasbourg

    Strasbourg, 67098

  • Service de Médecine Interne

    Toulouse, 31059

  • Department of clinical hematology

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

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

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.

Read more

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.

Being tested
BEVACIZUMAB
Keywords
Myelodysplastic syndromes (int-1, int-2 and high risk according to IPSS) with excess of marrow blasts including CMML with leucocytes<10 000/mm3
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00565656
Study groupRoleWhat they receive
AExperimentalBevacizumab
Receives: Drug: BEVACIZUMAB

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (1)

  1. The secondary endpoints will be survival, side effects

    Measured: weekly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2009
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00565656
Sponsor's protocol ID
06-PP-05
Other IDs
AFSSAPS number:060748
Status last verified
Jun 2009
First submitted
28 Nov 2007
Last updated
8 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEVACIZUMAB in people with Myelodysplastic Syndromes, run by Centre Hospitalier Universitaire de Nice at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00565656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.

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