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Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleEfficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)
Current status of trialActive, not recruiting
Sponsors and collaboratorsNovartis Pharmaceuticals
Information provided byNovartis
ClinicalTrials.gov identifierNCT00718263
PurposeThis study will evaluate the safety and tolerability of nilotinib after failure of imatinib
therapy or imatinib therapy after nilotinib failure.
Condition(s)Myelogenous Leukemia, Chronic
Intervention(s)Drug: Nilotinib
Drug: Imatinib
PhasePhase III
Study type and designAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleExtension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Primary outcomeTo compare the efficacy (MMR rate at 12 months) of nilotinib at 400mg/300mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosome-positive CML-CP patients. 12 months No
Secondary outcomeTo compare the rate of durable MMR at 24 months, which is defined as the proportion of patients who have achieved MMR by 12 months, and also maintain continuous MMR until the 24 month timepoint. 24 months No
Study startApril 2008
Minimum age18 Years
Maximum ageN/A
GenderBoth
Eligibility criteriaInclusion criteria:

1. Male or female patients â¿¥ 18 years of age.

2. ECOG 0, 1, or 2.

3. Patients with Ph+ CML who have failed treatment in the core protocol.

4. Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of
Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a
minimum 20 metaphases is required).

5. Adequate end organ function as defined by:

- Total bilirubin < 1.5 x ULN,

- SGOT and SGPT < 2.5 x ULN,

- Creatinine < 1.5 x ULN,

- Serum amylase and lipase ⿤ 1.5 x ULN,

- Alkaline phosphatase ⿤ 2.5 x ULN unless considered tumor related.

6. Patients must have the following laboratory values (â¿¥ LLN (lower limit of normal) or
corrected to within normal limits with supplements prior to the first dose of study
medication.):

- Potassium â¿¥ LLN,

- Magnesium â¿¥ LLN,

- Phosphorus â¿¥ LLN,

- Total calcium (corrected for serum albumin) â¿¥ LLN.

Exclusion criteria:

1. Previously documented T315I mutations.

2. Impaired cardiac function including any one of the following:

- LVEF < 45% or below the institutional lower limit of the normal range (whichever
is higher) as determined by locally read echocardiogram.

- Inability to determine the QT interval on ECG.

- Complete left bundle branch block.

- Use of a ventricular-paced pacemaker.

- Congenital long QT syndrome or a known family history of long QT syndrome.

- History of or presence of clinically significant ventricular or atrial
tachyarrhythmias.
Study chairs or principal investigatorsNovartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Study ID numbersCAMN107A2303E1
Last updatedJanuary 27, 2010
Record first receivedJune 3, 2008
ClinicalTrials.gov identifierNCT00718263
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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