A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase
18 Years
N/A
Both
Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive
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 Center | Houston, Texas 77030 |
