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Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis

Inclusion Criteria:

- Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis,
and polycythemia vera related myelofibrosis requiring therapy, including those
previously treated and relapsed or refractory, or, if newly diagnosed, with
intermediate or high risk according to Lille scoring system

- Patients not willing to undergo, not a candidate for, or not having a donor for a
bone marrow transplant.

- Signed informed consent: Patients must have signed consents for both the bevacizumab
protocol and for the mandatory biomarker MDP-RC 107 protocol to be eligible to

- Patients must have been off any IM-directed therapy for 2 weeks prior to entering
this study and have recovered from the toxic effects (grade 0-1) of that therapy.

- Serum bilirubin levels less than or equal to 2 times the upper limit of the normal
range for the laboratory (ULN). Higher levels are acceptable if these can be
attributed by treating physician to active hemolysis or ineffective erythropoiesis
due to myelofibrosis;

- Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels
less than or equal to 2x ULN.

- Serum creatinine levels less than or equal to 1.5 x ULN.

- Women of childbearing potential must have a negative serum or urine pregnancy test
prior to bevacizumab treatment and should be advised to avoid becoming pregnant. Men
must be advised to not father a child while receiving treatment with bevacizumab.
Both women of childbearing potential and men must practice effective methods of
contraception (those generally accepted as standard of care measures). Women of
child bearing potential are women who are not menopausal for 12 months or who have
not undergone previous surgical sterilization.

- Age > 18 years.

- LVEF >50% by MUGA or ECHO (only in patients with prior exposure to anthracyclines).

Exclusion Criteria:

- Nursing and pregnant females. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician

- Inadequately controlled hypertension (defined as systolic blood pressure >140 and/or
diastolic blood pressure >90 mmHg on antihypertensive medications) within 4 weeks
prior to entering this study

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Unstable angina

- History of myocardial infarction within 6 months

- History of stroke or transient ischemic attack within 6 months

- History of Budd-Chiari Syndrome or portal vein thrombosis.

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or clinically significant coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28
days, or anticipation of the need for major surgical procedure during the course of
the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device or bone marrow biopsy, within 7 days prior to study enrollment

- Proteinuria at screening as demonstrated by either

- Urine protein:creatinine (UPC) ratio greater than or equal to 1.0 at screening

- Urinalysis with proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on
dipstick urinalysis at baseline should undergo a 24 hour urine collection and
must demonstrate ≤ 1g of protein in 24 hours to be eligible).

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

- Ongoing serious, non-healing wound, ulcer, or bone fracture

- Known hypersensitivity to any component of bevacizumab

- Patients with a history of DVT and/or a CNS thrombotic or hemorrhagic event within
the past 6 months.

- Patients on anticoagulation therapy for a variety of conditions such as prosthetic
heart valves or chronic atrial fibrillation.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the safety and efficacy of bevacizumab treatment in patients with idiopathic myelofibrosis (IM)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ronald Hoffman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Myeloproliferative Disorders-Research Consortium


United States: Food and Drug Administration

Study ID:

MPD-RC 103



Start Date:

March 2008

Completion Date:

March 2010

Related Keywords:

  • Myelofibrosis
  • Myelofibrosis
  • Idiopathic
  • Bevacizumab
  • Avastin
  • bone marrow fibrosis
  • bone marrow angiogenesis
  • JAK2
  • Primary Myelofibrosis



MD Anderson Cancer Center Houston, Texas  77030-4096
University of Illinois at Chicago Chicago, Illinois  60612
Mount Sinai Medical Center New York, New York  10029
Georgetown University Washington, District of Columbia  20007-2197
Weill Cornell Ithaca, New York  14851