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

Primary Purpose

Chronic Myeloid Leukemia

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Nilotinib 150 MG [Tasigna]
Imatinib 400mg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Chronic phase CML treated by nilotinib

    Chronic phase CML treated by imatinib

    Arm Description

    Newly diagnosed

    Newly diagnosed

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 16, 2017
    Last Updated
    October 7, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03228303
    Brief Title
    Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
    Official Title
    Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2017 (Anticipated)
    Primary Completion Date
    July 30, 2020 (Anticipated)
    Study Completion Date
    August 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    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

    5. Study Description

    Brief Summary
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP
    Detailed Description
    Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Myeloid Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chronic phase CML treated by nilotinib
    Arm Type
    Active Comparator
    Arm Description
    Newly diagnosed
    Arm Title
    Chronic phase CML treated by imatinib
    Arm Type
    Active Comparator
    Arm Description
    Newly diagnosed
    Intervention Type
    Drug
    Intervention Name(s)
    Nilotinib 150 MG [Tasigna]
    Intervention Description
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP
    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib 400mg
    Intervention Description
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP
    Primary Outcome Measure Information:
    Title
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
    Description
    Overall survival rate in years
    Time Frame
    3 years cutoff
    Title
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
    Description
    cholesterol level in mg
    Time Frame
    3 years cutoff
    Title
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
    Description
    heart state by assessment by ECG
    Time Frame
    3 years cutoff
    Title
    Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
    Description
    free survival rate in years
    Time Frame
    3 years cutoff

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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