CompletedPhase 2

Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

Italy129 participantsStarted 2009-02-09

Plain-language summary

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.

Who can participate

Age range

18 Years – 120 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.

DISEASE CHARACTERISTICS: * Cytologically and cytogenetically confirmed chronic myelogenous leukemia meeting the following criteria: * Early chronic phase disease (\< 6 months from diagnosis) * Philadelphia chromosome-positive disease * BCR-ABL-positive PATIENT CHARACTERISTICS: * WHO performance status 0-1 * ALT and AST = 2.5 times upper limit of normal (ULN) (5.0 times ULN if considered due to leukemia) * Alkaline phosphatase = 2.5 times ULN (unless considered due to leukemia) * Serum bilirubin = 1.5 times ULN * Serum creatinine = 1.5 times ULN * Serum amylase = 1.5 times ULN * Serum lipase = 1.5 times ULN * Normal serum levels of the following or correctable with supplements: * Potassium * Total calcium (corrected for serum albumin) * Magnesium * Phosphorus * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier method contraception during study and for up to 3 months following completion of study treatment * No impaired cardiac function, including any of the following: * LVEF \< 45% by MUGA scan or echocardiogram * Uncontrolled congestive heart failure * Uncontrolled hypertension * Uncontrolled angina pectoris * Myocardial infarction within the past 12 months * No significant electric heart abnormalities, including any of the following: * History or active ventricular or atrial tachyarrhythmias * Congenital long QT syndrome and/or QTc \> 450 msec on screening ECG * No history of acute (within one y…

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

Complete cytogenetic response rate

Timeframe: At 12 months from study entry

Trial details

NCT IDNCT00769327

SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

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