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Extension 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)

Phase 3
18 Years
Open (Enrolling)
Myelogenous Leukemia, Chronic

Thank you

Trial Information

Extension 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)

Inclusion Criteria

Inclusion criteria:

1. Male or female patients ≥ 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 (≥ LLN (lower limit of normal) or
corrected to within normal limits with supplements prior to the first dose of study

- Potassium ≥ LLN,

- Magnesium ≥ LLN,

- Phosphorus ≥ LLN,

- Total calcium (corrected for serum albumin) ≥ 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To 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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

October 2018

Related Keywords:

  • Myelogenous Leukemia, Chronic
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease



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Hackensack University Medical Center Department of Research Hackensack, New Jersey  07601
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UNC/Lineberg Comprehensive Cancer Center UNC Lineberger Cancer Center Chapel Hill, North Carolina  27514
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