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

Stopped early · Phase 2

Conditions studied: Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive

In brief

This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia

Key facts

Study ID: NCT00023920
Run by: National Cancer Institute (NCI)
People needed: 60
Starts: 2001-07-01
Last updated by the study team: 2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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