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Therapy of Early Chronic Phase CML With Gleevec

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048672
Recruitment Status : Completed
First Posted : November 6, 2002
Last Update Posted : January 20, 2016
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to see if imatinib mesylate (Gleevec, STI571) can improve CML in chronic phase.


Primary Objective:

To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive early chronic phase CML using initial Gleevec therapy.

Secondary Objective:

To evaluate the duration of cytogenetic response, duration of hematologic response and survival.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic-Phase Drug: Gleevec Phase 2

Detailed Description:

Before treatment starts, patients will have a physical exam including medical history and documentation of disease, blood tests, and a bone marrow study. The bone marrow will be removed with a large needle.

Patients on this study will take 400 mg of imatinib daily (morning or evening). If you have side effects, the dose may be lowered. If the response is not good, the dose of imatinib mesylate will be increased to 800 mg daily (400 mg in the morning and 400 mg in the evening) or may be decreased to 300 mg daily based on how the drug is tolerated. Imatinib mesylate should be taken with a large glass of water. Bottles containing the tablets will be given to the patient every 6 months. Unused supplies must be returned at the end of the study.

After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated. If the response is good, treatment with imatinib mesylate alone will be continued. Treatment may be continued for up to 20 years, or as long as it is judged best to control the leukemia.

Update: June 2010:

Blood tests are recommended 2 times per year. Your doctor will discuss with you how often you should have blood tests. Bone marrow will be done if your doctor thinks it is necessary to check your disease. You must return to MD Anderson at least once every year. You may not need a bone marrow test every visit, but you will have blood drawn to measure the amount of disease you have. If the leukemia cannot be found for 2 years or longer on the blood test called PCR which is done to measure the amount of disease you have, your doctor may talk to you about stopping treatment with imatinib. If you and your doctor decide to stop your therapy, you will have a blood test for PCR done every 3 to 6 months. You do not need to return to MD Anderson to have this blood test done. You may have the blood taken by your local doctor and mailed to MD Anderson. If the leukemia is found again by the PCR blood test, your doctor may recommend that you restart treatment with imatinib. You may decide to stay on treatment with imatinib even if your PCR blood test does not show any sign of leukemia for 2 years or longer.

This is an investigational study. Imatinib mesylate has been approved in CML. A total of 50 patients will take part in this study. All will be enrolled at MD Anderson.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Gleevec (STI571)
Study Start Date : March 2001
Actual Primary Completion Date : November 2002
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Gleevec
Gleevec 400 mg orally daily. Dose adjustments made at discretion of treating physician within these guidelines: The highest dose acceptable is 800 mg daily. The lowest dose acceptable is 300 mg. No dose adjustment of more than 200 mg at one time is allowed. Dose adjustments to less than 300 mg may be approved after consultation with the principal investigator.
Drug: Gleevec
Starting dose of 400 mg orally daily.
Other Names:
  • Imatinib Mesylate
  • STI-571

Primary Outcome Measures :
  1. Number of patients achieving complete cytogenetic response using initial Gleevec therapy [ Time Frame: Baseline to 12 Months ]

Secondary Outcome Measures :
  1. Duration of cytogenic response, hematologic response and survival [ Time Frame: Baseline, 12 Months, 2 Years or until disease progression ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of Philadelphia chromosome (Ph)- positive or breakpoint cluster region (bcr)-positive CML in early chronic (diagnosis < 12 months).
  2. Age 15 years or above
  3. Adequate renal, hepatic, cardiac and performance status (ECOG 0-2) - no psychiatric disability (psychosis)
  4. Signed informed consent

Exclusion Criteria:

  1. Grade 3-4 cardiac
  2. Psychiatric problem
  3. Pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048672

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
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Principal Investigator: Jorge E Cortes, MD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00048672    
Other Study ID Numbers: ID01-015
First Posted: November 6, 2002    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by M.D. Anderson Cancer Center:
Early Chronic Phase Chronic Myelogenous Leukemia
Imatinib mesylate
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action