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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 PlainsAmarillo, Texas  79106
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)Las Vegas, Nevada  89109