Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous… (NCT00769327) | Clinical Trial Compass
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 range18 Years – 120 Years
SexALL
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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…
What they're measuring
1
Complete cytogenetic response rate
Timeframe: At 12 months from study entry
Trial details
NCT IDNCT00769327
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto