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Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia

NCT ID: NCT03228303

Last Updated: 2017-10-10

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-08-01

Brief Summary

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Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Detailed Description

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Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt

Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chronic phase CML treated by nilotinib

Newly diagnosed

Group Type ACTIVE_COMPARATOR

Nilotinib 150 MG [Tasigna]

Intervention Type DRUG

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Chronic phase CML treated by imatinib

Newly diagnosed

Group Type ACTIVE_COMPARATOR

Imatinib 400mg

Intervention Type DRUG

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Interventions

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Nilotinib 150 MG [Tasigna]

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Intervention Type DRUG

Imatinib 400mg

Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* chronic phase CML not received treatment
* Pts with no heart disease
* Pts with no abnormal cholesterol level

Exclusion Criteria

* Any pts treated before with diff. Treatment
* Pts. With past history of heart problems
* Pts. With abnormal cholesterol level
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Jean George Maxwell

ClinIcal professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Jgmaxwell

Identifier Type: -

Identifier Source: org_study_id