Can a cheaper, easier drug keep CML at bay after stronger treatment?
NCT ID NCT01316250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether people with chronic myeloid leukemia (CML) who had a good response to the drug nilotinib could switch to imatinib to maintain that response. The goal was to see if imatinib could keep the cancer under control while being easier to take and less expensive. Thirteen newly diagnosed adults participated in this small trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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13 people
The number who actually took part.
- Started
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Aug 2010
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Newly diagnosed untreated Philadelphia chromosome-positive CML (use of hydroxyurea for \<3 months is allowed) in chronic phase defined with the following criteria: * \<15% blasts in peripheral blood (PB) \& bone marrow (BM) * \<30% blasts plus promyelocytes in PB \& BM * \<20% basophils in PB * ≥100 x 109/L platelets * No evidence of extramedullary involvement, with the exception of liver \& spleen 2. Patients (pts) ≥18 yrs of age 3. WHO Performance Status of ≤2 4. Pts must have the following laboratory values: * Potassium within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication * Total calcium (corrected for serum albumin) and magnesium within normal limits or correctable with supplements * Phosphorus ≥ lower limit of normal (LLN) or correctable with supplements * ALT and AST ≤2.5 x upper limit of normal (ULN) or ≤5.0xULN if considered due to tumor * Alkaline phosphatase ≤2.5xULN * Serum bilirubin ≤1.5xULN * Serum Cr ≤1.5xULN or 24-hour Cr Cl ≥50 ml/min * Serum amylase ≤1.5xULN and serum lipase ≤1.5xULN 5. Written signed informed consent prior to any study procedures Exclusion Criteria: 1. Cytopathologically confirmed central nervous system (CNS) infiltration 2. Impaired cardiac function, including any one of the following: * Left ventricle ejection fraction (LVEF) \<45% or below the institutional lower limit of the normal range (whichever is higher) as determined by MUGA scan or echocardiogram * Complete left bundle branch block * Use of a pacemaker * ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads * Congenital long QT syndrome * History of or presence of significant ventricular or atrial tachyarrhythmias * Clinically significant resting bradycardia (\<50 beats/min) * QTc \>450 msec on screening ECG * Right bundle branch block plus left anterior hemiblock, bifascicular block * Myocardial infarction within 12 months prior to starting nilotinib * Unstable angina diagnosed or treated during the past 12 months * Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, or history of labile hypertension) 3. Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol) up to day before study drug administration 4. Acute or chronic liver or renal disease considered unrelated to tumor such as active Hepatitis A, B, or C 5. Other concurrent severe and/or uncontrolled medical conditions 6. Pts who are currently receiving treatment with any of the medications that have the potential to prolong QT interval 7. Pts who have received any investigational drug ≤4 weeks or investigational cytotoxic agent within 1 week (or who are within 5 half-lives of a previous investigational cytotoxic agent) prior to starting study drug or who have not recovered from side effects of such therapy 8. Pts who have received wide field radiotherapy ≤4 weeks or limited field radiation for palliation \<2 weeks prior to starting study drug or who have not recovered from side effects of such therapy 9. Pts who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy 10. Known diagnosis of HIV 11. Pt with a history of another malignancy that is currently clinically significant or currently requires active intervention 12. Pts who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to drug administration). Post menopausal women must be amenorrheic for at least 12 months. Male \& female pts must agree to employ an effective method of birth control throughout the study and for 3 months following discontinuation of study drug 13. Pts unwilling or unable to comply with protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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American University of Beirut Medical Center
Beirut, Lebanon
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Other studies related to the condition(s) this trial covers.
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