MedDataX Logo

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

NCT ID: NCT00081926

Last Updated: 2009-11-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Myelogenous Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CML Chronic Myelogenous Leukemia RIGHT Trial US177 CSTI571

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gleevec

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis RIGHT Trial Hotline

East Hanover, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Cortes JE, Kantarjian HM, Goldberg SL, Powell BL, Giles FJ, Wetzler M, Akard L, Burke JM, Kerr R, Saleh M, Salvado A, McDougall K, Albitar M, Radich J; Rationale and Insight for Gleevec High-Dose Therapy (RIGHT) Trial Study Group. High-dose imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: high rates of rapid cytogenetic and molecular responses. J Clin Oncol. 2009 Oct 1;27(28):4754-9. doi: 10.1200/JCO.2008.20.3869. Epub 2009 Aug 31.

Reference Type DERIVED
PMID: 19720924 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.novartisclinicaltrials.com

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

US177

Identifier Type: -

Identifier Source: secondary_id

RIGHT Trial

Identifier Type: -

Identifier Source: secondary_id

CSTI571AUS177

Identifier Type: -

Identifier Source: org_study_id