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A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Phase 4
18 Years
Open (Enrolling)
Chronic Myelogenous Leukemia in Chronic Phase

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Trial Information

A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years
of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with
the following exception: While awaiting study start, patients may be treated with
anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit),
and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for
frontline treatment. Patients taking a TKI prior to study entry must have at least a one
day washout from their last dose of medication and have recovered from any side effects of
such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to
receiving nilotinib, including concomitant medications.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of confirmed Complete Molecular Response (CMR)

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

December 2017

Related Keywords:

  • Chronic Myelogenous Leukemia in Chronic Phase
  • CML
  • Chronic Myelogenous Leukemia
  • Leukemia
  • CML-CP
  • Nilotinib
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome



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