Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI	MDA-ID-00323 NCI-2431, 2431, NCT00023920

Objectives

1. Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in patients with blastic phase chronic myelogenous leukemia.
2. Determine the toxicity profile of this regimen in these patients.
3. Determine the effect of bevacizumab on angiogenesis in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis
• Prior hydroxyurea allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Prior imatinib mesylate allowed
• At least 10 days since prior anticoagulants
• No concurrent anticoagulants

Patient Characteristics:

Age:

• Over 18

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 8 weeks

Hematopoietic:

• No prior coagulopathies

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• INR less than 2
• PTT no greater than 60 seconds

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 60 mL/min
• No nephrotic syndrome

Cardiovascular:

• No uncontrolled hypertension
• No New York Heart Association class II-IV heart disease
• No prior thrombotic events
• LVEF ≥ 50%

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

Approximately 20-60 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jorge Cortes, MD, Protocol chair		Ph: 713-794-5783; 800-392-1611 Email: jcortes@mdanderson.org

Registry Information
Official Title		A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients with Chronic Myeloid Leukemia in Blast Phase
Trial Start Date		2001-07-13
Registered in ClinicalTrials.gov		NCT00023920
Date Submitted to PDQ		2001-07-10
Information Last Verified		2004-01-09
NCI Grant/Contract Number		P30-CA16672, U01-CA62461

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