Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Stopped early · Phase 2
Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Myeloblastic Leukemia Without Maturation (M1), Childhood Acute Myelomonocytic Leukemia (M4), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
In brief
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. Bevacizumab may stop the growth of cancer by stopping blood flow to the leukemic cells in the bone marrow. Giving idarubicin and cytarabine with bevacizumab may kill more cancer cells. It is not yet know whether giving idarubicin together with cytarabine is more effective with or without bevacizumab in treating acute myeloid leukemia. This randomized phase II trial is studying how well giving idarubicin and cytarabine together with bevacizumab works compared to idarubicin and cytarabine alone in treating patients with newly diagnosed acute myeloid leukemia
Key facts
- Study ID
- NCT00096148
- Run by
- National Cancer Institute (NCI)
- People needed
- 120
- Starts
- 2004-10-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: any, up to 59. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed acute myeloid leukemia (AML)
- No acute promyelocytic leukemia
- None of the following cytogenetic abnormalities*:
- t(8;21)
- t(16;16)
- inv(16)
- No history or clinical evidence of primary brain tumors or brain metastasis
- Performance status - ECOG 0-2
- No bleeding diathesis or coagulopathy (unless related to AML)
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 times ULN
- No proteinuria
- No more than 1 g of protein on 24-hour urine collection
- LVEF ≥ 50%
- No uncontrolled hypertension
- No New York Heart Association class II-IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- No peripheral vascular disease ≥ grade II
- No stroke within the past 6 months
- No arterial thromboembolic event within the past 6 months, including any of the following:
- Transient ischemic attack
- Cerebrovascular accident
- Myocardial infarction
- Unstable angina
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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