- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048672
Therapy of Early Chronic Phase CML With Gleevec
Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Gleevec (STI571)
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Philadelphia chromosome (Ph)- positive or breakpoint cluster region (bcr)-positive CML in early chronic (diagnosis < 12 months).
- Age 15 years or above
- Adequate renal, hepatic, cardiac and performance status (ECOG 0-2) - no psychiatric disability (psychosis)
- Signed informed consent
Exclusion Criteria:
- Grade 3-4 cardiac
- Psychiatric problem
- Pregnant or lactating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Starting dose of 400 mg orally daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients achieving complete cytogenetic response using initial Gleevec therapy
Time Frame: Baseline to 12 Months
|
Baseline to 12 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of cytogenic response, hematologic response and survival
Time Frame: Baseline, 12 Months, 2 Years or until disease progression
|
Baseline, 12 Months, 2 Years or until disease progression
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge E Cortes, MD, M.D. Anderson Cancer Center
Publications and helpful links
General Publications
- Jain P, Kantarjian H, Boddu PC, Nogueras-Gonzalez GM, Verstovsek S, Garcia-Manero G, Borthakur G, Sasaki K, Kadia TM, Sam P, Ahaneku H, O'Brien S, Estrov Z, Ravandi F, Jabbour E, Cortes JE. Analysis of cardiovascular and arteriothrombotic adverse events in chronic-phase CML patients after frontline TKIs. Blood Adv. 2019 Mar 26;3(6):851-861. doi: 10.1182/bloodadvances.2018025874.
- Issa GC, Kantarjian HM, Gonzalez GN, Borthakur G, Tang G, Wierda W, Sasaki K, Short NJ, Ravandi F, Kadia T, Patel K, Luthra R, Ferrajoli A, Garcia-Manero G, Rios MB, Dellasala S, Jabbour E, Cortes JE. Clonal chromosomal abnormalities appearing in Philadelphia chromosome-negative metaphases during CML treatment. Blood. 2017 Nov 9;130(19):2084-2091. doi: 10.1182/blood-2017-07-792143. Epub 2017 Aug 23.
- Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- ID01-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia, Myeloid, Chronic-Phase
-
Asan Medical CenterTerminatedLeukemia, Chronic Myeloid | Myeloid Leukemia, Chronic, Chronic Phase | Myeloid Leukemia, Chronic, Accelerated PhaseKorea, Republic of
-
ChemGenex PharmaceuticalsTerminatedMyeloid Leukemia, Chronic, Chronic-Phase | Myeloid Leukemia, Chronic | Myeloid Leukemia, Chronic, Accelerated-Phase | Blast PhaseUnited States
-
Newcastle UniversityBristol-Myers Squibb; Institute of Cancer Research, United Kingdom; Newcastle-upon-Tyne... and other collaboratorsCompletedMyeloid Leukemia, Chronic, Chronic PhaseUnited Kingdom
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.RecruitingCML, Chronic Phase | CML, Accelerated PhaseChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedChronic Myelogenous Leukemia - Chronic PhaseChina
-
Fundacion Espanola para la Curacion de la Leucemia...Pfizer; Roche Farma, S.ATerminatedChronic Phase-Chronic Myeloid LeukemiaSpain
-
TakedaActive, not recruitingMyeloid Leukemia, Chronic, Chronic PhaseUnited States, Spain, Taiwan, Australia, Canada, Russian Federation, Sweden, Switzerland, Germany, United Kingdom, Poland, Korea, Republic of, Argentina, Hong Kong, Singapore, Italy, Chile, Czechia, Denmark, France, Portugal
-
H. Lee Moffitt Cancer Center and Research InstituteIncyte Corporation; H. Jean Khoury Cure CML ConsortiumRecruitingChronic Myeloid Leukemia, Chronic Phase | Chronic Phase Chronic Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)TerminatedAccelerated Phase Chronic Myelogenous Leukemia | Chronic Phase Chronic Myelogenous Leukemia | Relapsing Chronic Myelogenous Leukemia | Chronic Myelogenous Leukemia, BCR-ABL1 PositiveUnited States
-
Korean Society of HematologyNot yet recruitingChronic Myeloid Leukemia, Chronic Phase
Clinical Trials on Gleevec
-
M.D. Anderson Cancer CenterNovartis PharmaceuticalsCompletedPolycythemia Vera | Chronic Myelomonocytic Leukemia | Hypereosinophilic Syndrome | Chronic Myeloid Leukemia | MastocytosisUnited States
-
National Cancer Institute (NCI)CompletedSclerotic Graft Versus Host Disease | Imatinib MesylateUnited States
-
M.D. Anderson Cancer CenterNovartisCompletedGastrointestinal Stromal TumorsUnited States
-
M.D. Anderson Cancer CenterNovartisCompletedAcute Myelogenous Leukemia | Chronic Myelogenous Leukemia | Agnogenic Myeloid MetaplasiaUnited States
-
Jewish General HospitalNovartis PharmaceuticalsTerminatedChronic Lymphocytic LeukemiaCanada
-
M.D. Anderson Cancer CenterCompletedChronic Myelogenous LeukemiaUnited States
-
University of PittsburghNovartisCompleted
-
Annick DesjardinsAstraZeneca; Novartis PharmaceuticalsCompletedGlioblastoma | GliosarcomaUnited States
-
Steven E. CoutreNovartisTerminatedEosinophilia | Hypereosinophilic SyndromeUnited States
-
Indiana UniversityTerminatedPulmonary HypertensionUnited States