Completed

Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

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What is being tested

Data Collection

Who is being recruted

Bone Marrow Diseases
+8

+ Chronic Disease
+ Hematologic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with CML. Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML.

Official TitleGleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia 
NCT00081926
Principal SponsorNovartis Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
112 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bone Marrow Diseases
Chronic Disease
Hematologic Diseases
Leukemia
Leukemia, Myeloid
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Disease Attributes
Criteria

Inclusion Criteria: Participants must meet all of the following criteria: * Male or Female patients 18 years and older. * Patient with a diagnosis of chronic myelogenous leukemia in chronic phase * Within 6 months of initial diagnosis. * Received any treatment for CML for less than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide. Exclusion Criteria: * Late chronic phase, accelerated phase or blastic phase * Taking any other investigational agents within 28 days of starting the study * If sibling donors have been identified and where allogeneic bone marrow transplantation will be the first line treatment. * Another primary malignancy /cancer unless it is not considered clinically significant or does not require active intervention. * If patients have heart problems or complications * Pregnant or breast-feeding females * Severe and/or uncontrolled disease such as diabetes, chronic renal disease, etc. * Chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). * Diagnosis of human immunodeficiency virus (HIV) infection. * Received any treatment for CML for longer than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide. * Patient previously received radiotherapy to greater than 25% of the bone marrow. * Patient had a major surgery within 4 weeks prior to study entry



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Novartis RIGHT Trial HotlineEast Hanover, United StatesSee the location

CompletedOne Study Center
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