Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C

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: NCT00038649
Recruitment Status : Terminated (Sponsor discontinued providing study drug.)
First Posted : June 4, 2002
Last Update Posted : December 9, 2013
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 higher doses of imatinib mesylate (Gleevec, STI571) can improve chronic myelogenous leukemia (CML) in chronic phase.

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

Detailed Description:

Imatinib mesylate is a new oral medication that blocks a protein that is responsible for CML

Before treatment starts, patients will have a physical exam, blood tests, and a bone marrow study. The bone marrow will be removed with a large needle. Women able to have children will have a screening blood or urine test for pregnancy.

Patients on this study will take 400 mg of imatinib twice daily (morning and evening). If you have side effects, the dose may be lowered. If you are taking less than 800 mg of imatinib, you can take your dose once per day or divided in two doses. 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 M. D. 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 M. D. Anderson to have this blood test done. You may have the blood taken by your local doctor and mailed to M. D. 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 125 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Higher-Dose Gleevec (STI571)
Study Start Date : June 2001
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Gleevec
Gleevec 400 mg orally twice daily.
Drug: Gleevec
400 mg orally twice daily
Other Names:
  • imatinib mesylate
  • STI-571

Primary Outcome Measures :
  1. Molecular Response [ Time Frame: 3 - 12 months ]
    After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated.

Information from the National Library of Medicine

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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. Patients age 15 years or older with a diagnosis of Ph-positive or Bcr-positive CML in early chronic phase CML (diagnosis < 12 months). Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as less than 1 month of prior IFN-a or ara-C.
  2. ECOG performance of 0-2
  3. Serum bilirubin less than 2 mg%, serum creatinine less than 2mg%
  4. Women of pregnancy potential must practice contraception. Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.
  5. Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
  6. The definitions of CML phases are as follows: a) early chronic phase: time from diagnosis to therapy < 12 months, late chronic phase: time from diagnosis to therapy > 12 months; b) blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow; c) accelerated phase CML: presence of any of the following features: peripheral or marrow blasts 15% or more, peripheral or marrow basophils 20% or more, thrombocytopenia <100 x 10(9)/L unrelated to therapy, documented extramedullary blastic disease outside liver or spleen due to past causes
  7. The definitions of CML phases are as follows: clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-a therapy. Hence these patients will be eligible if no other accelerated phase signs are present, and analyzed separately.
  8. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the CML population. Their distribution is similar to the general referral profiles for CML: about 50% of CML patients are females and 25% to 30% are members of minorities. There are no exclusions of women or minorities based on the study objectives.

Exclusion Criteria:

  1. NYHA class 3-4 heart disease
  2. Psychiatric disability (psychosis)
  3. Pregnant or lactating females
  4. Patients in late chronic phase, accelerated phase or blastic phase are excluded.

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): NCT00038649

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Principal Investigator: Jorge E Cortes, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038649     History of Changes
Other Study ID Numbers: ID01-151
First Posted: June 4, 2002    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by M.D. Anderson Cancer Center:
Philadelphia chromosome positive
early chronic phase (diagnosis < 12 months)
Chronic Myelogenous Leukemia, Chronic Phase
Chronic Myelogenous Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Chronic Disease
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action