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A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase


Phase 2
18 Years
N/A
Not Enrolling
Both
Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive

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Trial Information

A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase


PRIMARY OBJECTIVES:

I. Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in
patients with blastic phase chronic myelogenous leukemia.

II. Determine the toxicity profile of this regimen in these patients. III. Determine the
effect of bevacizumab on angiogenesis in these patients.

OUTLINE:

Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive
bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine
subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a
maximum of 3 courses. Patients with responding disease receive maintenance therapy
comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and
cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in
the absence of disease progression or unacceptable toxicity.


Inclusion Criteria:



- Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous
leukemia (CML), defined by 1 of the following:

- At least 30% blasts in peripheral blood and/or bone marrow

- Presence of extramedullary disease

- Performance status - Zubrod 0-2

- At least 8 weeks

- No prior coagulopathies

- Bilirubin no greater than 1.5 mg/dL

- INR less than 2

- PTT no greater than 60 seconds

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No nephrotic syndrome

- No uncontrolled hypertension

- No New York Heart Association class II-IV heart disease

- No prior thrombotic events

- LVEF ≥ 50%

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No more than 2 prior chemotherapy regimens (no more than 1 regimen containing
cytarabine) for CML in blast crisis

- Prior hydroxyurea allowed

- Prior imatinib mesylate allowed

- At least 10 days since prior anticoagulants

- No concurrent anticoagulants

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Improvement in response rate

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Jorge Cortes

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02405

NCT ID:

NCT00023920

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Blastic Phase Chronic Myelogenous Leukemia
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030