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An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.


Phase 3
17 Years
N/A
Open (Enrolling)
Both
CHRONIC MYELOGENOUS LEUKEMIA

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Trial Information

An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.


Inclusion Criteria:



Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR
Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease
demonstrated by two PCR positive tests 3 months apart both during the past 6 months.

Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No
other current or planned anti-leukemia therapies

Exclusion Criteria:

Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months)
Patient has received another investigational agent within last 6 months or TKIs other than
imatinib Prior allogeneic stem cell transplantation

Impaired cardiac function including any one of the following:

Inability to monitor the QT interval on ECG Long QT syndrome or a known family history of
long QT syndrome. Clinically significant resting brachycardia (<50 beats per minute) QTc >
450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are
not within normal ranges, electrolytes should be corrected and then the patient
re-screened for QTc Myocardial infarction within 12 months prior to starting study Other
clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart
failure or uncontrolled hypertension) History of or presence of clinically significant
ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF,
GM-CSF or SCF) within 4 weeks prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply Other protocol related

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of confirmed best cumulative CMR within the first year of study therapy with imatinib or nilotinib

Outcome Time Frame:

12 months of treatment

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CAMN107A2405

NCT ID:

NCT00760877

Start Date:

June 2009

Completion Date:

May 2014

Related Keywords:

  • Chronic Myelogenous Leukemia
  • MYELOGENOUS
  • LEUKEMIA
  • Chronic Phase
  • CML
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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