Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.

The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.

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Detailed Description

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Conditions

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Leukemia, Myeloid, Chronic, BCR-ABL Positive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib and nilotinib combination

All patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months.

Group Type EXPERIMENTAL

Imatinib and Nilotinib

Intervention Type DRUG

Interventions

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Imatinib and Nilotinib

Intervention Type DRUG

Other Intervention Names

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Gleevec Tasigna

Eligibility Criteria

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Inclusion Criteria

* CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
* Patients with grade II or higher adverse events.
* CML patients not suitable for stem cell transplantation.