A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)



Status:Active, not recruiting
Conditions:Other Indications, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:12/27/2018
Start Date:July 31, 2007
End Date:December 31, 2018

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A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg
twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients
with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase
(CML-CP).

An extension protocol is included in this study design to allow patients who did not show
sufficient response to their assigned treatments the opportunity to receive nilotinib therapy
at a dose of 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

The extension protocol CAMN107A2303E1 (NCT00718263) was registered incorrectly as a separate
study. But this study has now been suppressed.


Inclusion criteria:

- Chronic myelogenous leukemia in chronic phase patients within the first 6 months of
diagnosis.

- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of
Philadelphia chromosome

Exclusion criteria:

- Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except
for no more than 2 weeks in duration of imatinib

- Any medical treatment for CML prior to study entry for longer than 2 weeks with the
exception of hydroxyurea and/or anagrelide

- 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, phenprocoumon)

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

Other protocol-defined inclusion/exclusion criteria may apply
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Caba, Buenos Aires
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Greenville, South Carolina 29605
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