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A Phase IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular Response on Imatinib


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Philadelphia Chromosome Positive, Chronic Myelogenous Leukemia in Chronic Phase

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Trial Information

A Phase IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular Response on Imatinib


Inclusion Criteria:



1. Male or female patients ≥ 18 years of age.

2. ECOG 0, 1, or 2.

3. Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.

4. Patients with suboptimal molecular response to imatinib treatment continued for at
least 18 months (first line therapy)

Suboptimal molecular response defined as all of the following conditions:

1. Patients who have achieved CCyR (0% Ph+ chromosomes).

2. Patients who don't achieve MMR (MMR defined as BCR-ABL/ABL ratio of ≤ 0.1% on
the International Scale as detected by RQ-PCR).

The treatment with imatinib defined as:

Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to
study entry.

5. Patients who meet the following laboratory tests criteria:

1. total bilirubin < 1.5 x ULN,

2. SGOT and SGPT < 2.5 x ULN,

3. creatinine < 1.5 x ULN,

4. Serum amylase and lipase ≤ 1.5 x ULN,

5. Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.

6. Serum potassium, phosphorus, magnesium and calcium ≥ LLN or correctable with
supplements prior to the first dose of study drug.

6. Written informed consent prior to any study related screening procedures being
performed.

Exclusion Criteria:

1. Prior accelerated phase or blast crisis CML.

2. Previously documented T315I mutations.

3. Presence of chromosomal abnormalities other than Ph+.

4. Previous treatment with any other tyrosine kinase inhibitor except imatinib.

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

1. Complete left bundle branch block

2. Congenital long QT syndrome or family history of long QT syndrome

3. History of or presence of significant ventricular or atrial tachyarrhythmias

4. Clinically significant resting brachycardia (<50 bpm)

5. QTcF > 450 msec on screening ECG

6. Use of a ventricular-paced pacemaker

7. Myocardial infarction during the last 12 months

8. Other clinically significant heart disease (e.g. congestive heart failure,
uncontrolled hypertension, unstable angina).

6. Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine,
rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment
cannot be discontinued or switched to a different medication prior to starting study
drug. See Section 6.4.3 for complete list of these medications.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the MMR rate at 12 months of nilotinib treatment on study in patients with Ph+ CML in CP who have a suboptimal molecular response to imatinib at 18 months or later.

Outcome Time Frame:

12 months after treatment

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107FJP01

NCT ID:

NCT01043874

Start Date:

December 2009

Completion Date:

February 2014

Related Keywords:

  • Philadelphia Chromosome Positive
  • Chronic Myelogenous Leukemia in Chronic Phase
  • Chronic phase
  • Chronic myelogenous leukemia
  • CML
  • Philadelphia chromosome positive
  • Ph+
  • Nilotinib
  • CML-CP
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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