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A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib

Phase 3
18 Years
Not Enrolling
Myelogenous Leukemia

Thank you

Trial Information

A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib

This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to
imatinib treatment in patients with suboptimal response to imatinib. The patients were
stratified by prior duration of initial imatinib treatment, and were randomized to receive
either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum
patients were treated with imatinib = 6 to < 12 months and having at least a minimal
cytogenetic, but no partial cytogenetic response; and the second stratum patients were
treated with imatinib = 12 months to < 18 months and having partial cytogenetic response
(PCyR), but no CCyR.

Inclusion Criteria

Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line
therapy) defined as:

- 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or

- 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics,
no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

- Patient who have received more than 18 months of imatinib therapy

- Patients who have achieved partial or complete cytogenetic response and lost that
response prior to entering the study.

- Prior treatment with greater than 400 mg/day imatinib.

- Uncontrolled or significant cardiovascular disease.

- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
uncontrolled infection).

- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol,

- Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

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

Outcome Measure:

Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib

Outcome Description:

Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.

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:

October 2007

Completion Date:

October 2008

Related Keywords:

  • Myelogenous Leukemia
  • leukemia
  • bone marrow
  • leukemia symptoms
  • cml
  • complete blood count
  • lymphocyte
  • blood cancer
  • leukocytes
  • chronic leukemia
  • bone marrow biopsy
  • leukemia research
  • leukemia cells
  • bone marrow disease
  • chronic myeloid leukemia
  • blood cancer symptoms
  • white blood cell diseases
  • chronic myelogenous leukemia
  • leukemia treatment
  • leukemia facts
  • leucemia
  • facts about leukemia
  • myelogenous leukemia
  • newly diagnosed CML
  • suboptimal response
  • Philadelphia chromosome positive (Ph+)
  • chronic myelogenous leukemia in chronic phase (CML-CP)
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



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