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

October 7, 2017 updated by: Jean George Maxwell, Assiut University
Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Chronic phase CML treated by nilotinib
Newly diagnosed
Drug: Nilotinib 150 MG [Tasigna]
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
ACTIVE_COMPARATOR: Chronic phase CML treated by imatinib
Newly diagnosed
Drug: Imatinib 400mg
Nilotinib vs imatinib in patients with newly diagnosed CML-CP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
Time Frame: 3 years cutoff
Overall survival rate in years
3 years cutoff
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
Time Frame: 3 years cutoff
cholesterol level in mg
3 years cutoff
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
Time Frame: 3 years cutoff
heart state by assessment by ECG
3 years cutoff
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
Time Frame: 3 years cutoff
free survival rate in years
3 years cutoff

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

July 30, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

July 16, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (ACTUAL)

July 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 7, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jgmaxwell

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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