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A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations


Phase 4
18 Years
N/A
Not Enrolling
Both
CML, Philadelphia Chromosome Positive (Ph+), Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels

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Trial Information

A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations


Inclusion Criteria:



- Ph+ CML-CP within 12 months of diagnosis

- Imatinib 400 mg qd for up to 12 months

- Imatinib trough plasma concentration <850 ng/mL

- Patient that have met response milestones including:

1. CHR and at least minor CyR (Ph+ ≤65%) at 3 months from diagnosis

2. At least pCyR at 6 months from diagnosis (Ph+ ≤35%)

3. CCyR at 12 months from diagnosis

Exclusion Criteria:

- Prior documented failure events including:

- Loss of CHR or CCyR

- Less than CHR (stable disease or disease progression) at 3 months after diagnosis

- No CyR at 6 months after diagnosis

- Less than PCyR at 12 months after diagnosis

- Prior accelerated phase or blast phase CML

- Previously documented T315I mutation

- Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

- Patients who had any other treatment for CML (transplant) except imatinib,
hydroxyurea and/or anagrelide

- Impaired cardiac function (refer to Section 5.2 for details)

- Patients receiving therapy with strong inhibitors of CYP3A4 or medications that
prolong the QT interval and cannot be either discontinued or switched to a different
medication prior to starting study drug.

- Any other malignancy that is clinically significant or requires active intervention.

- Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from
prior surgery.

- Treatment with other investigational agents within 30 days of Day 1.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the number of ELN-guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations (<850 ng/mL) treated with nilotinib.

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107AUS20

NCT ID:

NCT01131325

Start Date:

March 2010

Completion Date:

August 2011

Related Keywords:

  • CML
  • Philadelphia Chromosome Positive (Ph+)
  • Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
  • Philadelphia chromosome positive
  • Ph+
  • chronic myelogenous leukemia chronic phase
  • CML-CP
  • low imatinib trough levels
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease

Name

Location

Baylor Health Care System / Sammons Cancer Center Dept. of Sammons Cancer (2) Dallas, Texas  75246
Cancer Center of the High Plains Amarillo, Texas  79106
Comprehensive Cancer Centers of Nevada CCC of Nevada (1) Las Vegas, Nevada  89109