Neoplasms

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Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Cytarabine

Interferons

Interferon-alpha

Interferon-alfa-1b

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gleevec

Jorge E Cortes, MD

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.

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 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 polymerase chain reaction (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 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 MD Anderson.

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

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Higher-Dose Gleevec (STI571)

Complete Hematologic Remission (CHR): normalization \>4 weeks of bone marrow (\<5% blasts), peripheral blood with White Blood Cells (WBC) \<10 x 109/L \& no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \< 50% of pretreatment, or thrombocytosis \>450x109/L but \<50% of pretreatment. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.

Number of participants with Complete Hematologic Remission (CHR): normalization \>4 weeks of bone marrow (\<5% blasts), peripheral blood with WBC \<10 x 109/L \& no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. CHR further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or i Fluorescence In Situ Hybridization (FISH): No cytogenetic response - Ph positive 100% of pretreatment value; Minor cytogenetic response - Ph positive 35-90% of pretreatment value; Partial cytogenetic response - Ph positive 1-34% of pretreatment value; Complete cytogenetic response - Ph positive 0%. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.

Novartis Pharmaceuticals

M.D. Anderson Cancer Center

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jorge Cortes, MD/Professor, Leukemia Department

Number of Participants With Molecular Response of Complete or Partial Hematologic Remission

No cytogenetic response

Minor cytogenetic response

Partial cytogenetic response

Complete cytogenetic response

Analysis was of the 110 participants who achieved a CHR with a cytogenetic response as described in the outcome measure descriptions.

Participant Complete Hematologic Remission (CHR) Classified

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C	NCT00038649	Myelogenous Leu...	Gleevec	15 Years -	M.D. Anderson Cancer Center
Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C	NCT00038649	Myelogenous Leu...	Gleevec	15 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for early chronic phase (diagnosis < 12 months)