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

Primary Purpose

Chronic Myelogenous Leukemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gleevec
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring CML, Chronic Myelogenous Leukemia, RIGHT Trial, US177, CSTI571

Eligibility Criteria

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

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

Sites / Locations

  • Novartis RIGHT Trial Hotline

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 26, 2004
Last Updated
November 20, 2009
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00081926
Brief Title
Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia
Keywords
CML, Chronic Myelogenous Leukemia, RIGHT Trial, US177, CSTI571

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gleevec

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novartis RIGHT Trial Hotline
City
East Hanover
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19720924
Citation
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.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

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

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