Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
3 other identifiers
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 26, 2004
CompletedFirst Posted
Study publicly available on registry
April 29, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedNovember 23, 2009
November 1, 2009
April 26, 2004
November 20, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis RIGHT Trial Hotline
East Hanover, New Jersey, United States
Related Publications (1)
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.
PMID: 19720924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 26, 2004
First Posted
April 29, 2004
Study Start
October 1, 2003
Study Completion
March 1, 2007
Last Updated
November 23, 2009
Record last verified: 2009-11