Safety and Efficacy of CML Patients Who Switch to Nilotinib and Stop Treatment After Achieving and Sustaining MR4.5.



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/31/2018
Start Date:August 12, 2013
End Date:February 1, 2021

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A Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in
patients who achieve MR4.5


Inclusion Criteria:

- Diagnosis of CML

- Treated with at least 1 year of imatinib

- Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by
PCR reported on the International scale. This will be confirmed during screening

- Written informed consent obtained prior to any screening procedures performed

Exclusion Criteria:

- T315I mutation

- Prior imatinib failure or had accelerated phase or blast crisis CML

- Impaired cardiac function (defined futher in the protocol)

- Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply.
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601 Elmwood Avenue
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818 N. Emporia, #403
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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