Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

Gleevec

Jorge E Cortes, MD

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

Objectives:

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.

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.

Therapy of Early Chronic Phase CML With Gleevec

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

Novartis Pharmaceuticals

M.D. Anderson Cancer Center

Anti-Infective Agents

Molgramostim

Sargramostim

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon-alfa-1b

Interferon alpha-2

Antiviral Agents

Immunologic Factors

Gleevec 400 mg orally twice daily. Peg-Intron 0.5 mcg/kg each week subcutaneously. GM-CSF 125 mcg/m\^2 three times per week subcutaneously.

PEG-IFN 0.5 mcg/kg each week subcutaneously.

Peg-alpha interferon (Peg-Intron)

125 mcg/m\^2 three times per week subcutaneously.

Sargramostim (GM-CSF)

The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.

Imatinib mesylate is a drug that blocks a protein that is responsible for the development of CML. PEG-Intron is a natural substance made by the cells of the immune system and helps to control CML. GM-CSF is a hormone that helps to stimulate the production of white blood cells.

During the study you will take 400 mg of imatinib mesylate by mouth 2 times a day (800 mg a day total). Imatinib mesylate should be taken each morning and evening with a large glass of water. You may be given a "pill diary" to write down when (day and time) you take the drug. You may also write in the diary any side effects you may experience. You may bring the diary, any unused tablets, and empty bottles of imatinib mesylate with you to every visit to the study doctor. Any unused supplies must be returned at the end of the study.

After completing 6 months of imatinib mesylate therapy, you will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in the first group will be given PEG-Intron and GM-CSF in addition to imatinib mesylate therapy. Patients in the other group will continue taking only imatinib mesylate.

If you are assigned to the group that will receive PEG-Intron and GM-CSF, you will continue taking imatinib mesylate. In addition, PEG-Intron will be given as an injection under the skin once a week. Sargramostim will be given as an injection under the skin 3 times a week. You and/or your family members can be taught to give these injections.

Every 1-2 weeks during the first 4 weeks of the study, you will have around 2 teaspoons of blood drawn for routine blood tests and to measure the amount of imatinib in your blood. The blood tests will then be repeated every 6 to 8 weeks (or more often if your doctor feels it is necessary) for as long as you are on the study. A bone marrow sample will also be taken every 3 months for the first year and then every 4 to 6 months for as long as you are on the study to check on the status of the disease .

You will be asked to visit the doctor for a physical exam and to have vital signs measured. These visits will be scheduled at least every 3 months while you are on the study. The visits may be scheduled more often depending on the status of the disease.

Update: February 2012:

Blood test 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 needed to check the 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.

Treatment in both groups may be continued for up to 7-10 years, or as long as the doctor feels is necessary to control the leukemia.

If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

This is an investigational study. All of the drugs used in this study are FDA approved and commercially available. However, their use in this study is investigational. A total of 98 patients will take part in this study. All will be enrolled at MD Anderson.

High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)

Randomized Trial of Therapy of Early Phase Chronic Myelogenous Leukemia With High-Dose Imatinib Mesylate (Gleevec) Alone or in Combination With Peg-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF)

Duration measured in time from first response to disease progression; Cytogenetic (or FISH), and PCR quantification every 3-4 months as indicated in year one then FISH every 1-3 years and PCR every year

Complete Hematologic Remission (CHR) - normalization \>4 weeks of bone marrow (less than 5% blasts) \& peripheral blood with white blood count (WBC)\<10x10\^9/L \& no peripheral blasts, promyelocytes or myelocytes, disappearance of all signs \& symptoms of disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \<50% of pretreatment, or thrombocytosis \>450x10\^9/L but \<50% of pretreatment. Complete hematologic remission further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or fluorescence in situ hybridization (FISH): a) No cytogenetic response - Ph positive 100% of pretreatment value; b) Minor cytogenetic response - Ph positive 35-90% of pretreatment value; c) Partial cytogenetic response - Ph positive 1-34% of pretreatment value; d) Complete cytogenetic response - Ph positive 0%.

Novartis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapy of Early Chronic Phase CML With Gleevec	NCT00048672	Leukemia, Myelo...	Gleevec	15 Years -	M.D. Anderson Cancer Center
High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)	NCT00050531	Leukemia, Myelo...	Gleevec Peg-alpha inter... Sargramostim (G...	18 Years -	M.D. Anderson Cancer Center
Therapy of Early Chronic Phase CML With Gleevec	NCT00048672	Leukemia, Myelo...	Gleevec	15 Years -	M.D. Anderson Cancer Center
Therapy of Early Chronic Phase CML With Gleevec	NCT00048672	Leukemia, Myelo...	Gleevec	15 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for early chronic phase chronic myelogenous leukemia