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Phase 3
18 Years
80 Years
Open (Enrolling)
Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia

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Trial Information

Inclusion Criteria:

1. Male or female patients age more than 18 years old;

2. Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the
date of first cytogenetic analysis). Standard conventional cytogenetic analysis must
be done on bone marrow. FISH cannot be used.

3. Diagnosis of Chronic Myeloid leukemia in Chronic Phase (CML-CP) with cytogenetic
confirmation for the presence of Philadelphia chromosome (9;22 translocation); less
than 20 metaphases may be used for diagnosis;

4. Patients who are considered Ph negative because they do not have a confirmed
cytogenetic diagnosis of Philadelphia chromosome are eligible if they have no Ph+
chromosome (9;22 translocation) in > 20 metaphases and are positive for BCR-ABL
transcripts by PCR;

5. Patients with atypical BCR-ABL transcripts are eligible (transcripts other then b2a2
an b3a2);

6. No previous treatment with any antileukemic drugs with the exception of hydroxyurea
(HU), and/or anagrelide. In emergent cases where the patient requires disease
management while awaiting study start, commercial supplies of Gleevec/Glivec at any
dose may be prescribed to the patient but for no longer than 2 weeks in duration;

7. ECOG 0,1 or 2;

8. Normal serum levels > LLN (lower limit of normal) or corrected to within normal
limits with supplements, prior to the first dose of study medication, of potassium,
magnesium and calcium;

9. AST and ALT < 2.5 x ULN or < 5.0 x ULN if considered due to leukemia;

10. Alkaline phosphatase < 2.5 x ULN unless considered due to leukemia;

11. Total bilirubin < 1.5 x ULN;

12. Serum lipase and amylase < 1.5 x ULN;

13. Written informed consent prior to any study procedures being performed.

Exclusion criteria

1. Treatment with tyrosine kinase inhibitors or other antileukemic agents or treatments
(including HSCT) for longer than 2 weeks, with the exception of HU and/or anagrelide

2. Previously documented T315I mutations;

3. Uncontrolled congestive heart failure or hypertension;

4. Myocardial infarction or unstable angina pectoris within past 12 months;

5. Significant arrhythmias, including history or presence of clinically significant
ventricular or atrial tachyarrhythmias, clinically significant bradycardias, long QT
syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula). Patients
with complete LBBB;

6. History of confirmed acute or chronic pancreatitis;

7. Other concurrent uncontrolled medical conditions

8. Impaired gastrointestinal function or GI disease that may alter the absorption of
study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting and diarrhea,
malabsorption syndrome, small bowel resection or gastric by-pass surgery);

9. Patients with another primary malignancy that is currently clinically significant or
requires active intervention;

10. Concomitant medications with potential QT prolongation;

11. Concomitant medications known to interact with CYP450 isoenzymes

12. History of significant congenital or acquired bleeding disorder unrelated to cancer;

13. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or
who have not recovered from side effects of such therapy;

14. Patients who are pregnant or breast feeding or adults of reproductive potential not
employing an effective method of birth control. 15. Treatment with any hematopoietic
colony-stimulating growth factors (e.g. G-CSF, GM-CSF) 1 week prior to starting study

15. Treatment with other investigational agents (defined as not used in accordance with
the approved indication) within 30 days of Day 1;

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate efficacy, using molecular response, of nilotinib 300 mg BID in the treatment of newly diagnosed CML-CP patients.

Outcome Time Frame:

Two years.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive