TerminatedPhase 2

Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Stopped: Administratively complete.

United States120 participantsStarted 2004-10

Plain-language summary

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

Who can participate

Age range

59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * No other clinically significant cardiovascular disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3-4 months after study participation * No serious or non-healing wound ulcer or bone fracture * No uncontrolled infection * No significant traumatic injury within the past 28 days * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No history or clinical evi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients who remain alive in the first complete remission (CR) 1 year from achievement of CR assessed every 3 weeks for 1 year

Timeframe: 13 months from registration

Trial details

NCT IDNCT00096148

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2006-11

View on ClinicalTrials.gov More Adult Acute Basophilic Leukemia trials