Therapy of Early Chronic Phase CML With Gleevec - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Novartis Pharmaceuticals
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00048672

Purpose

The goal of this clinical research study is to see if imatinib mesylate (Gleevec, STI571) can improve CML in chronic phase. Extra blood and/or bone marrow samples will be taken upon permission, and these samples will be used to evaluate the effect of the treatment on leukemic cells.

Condition	Intervention	Phase
Leukemia, Myeloid, Chronic-Phase	Drug: Gleevec	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Gleevec (STI571)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive early chronic phase CML using initial Gleevec therapy. [ Time Frame: November 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the duration of cytogenic response, duration of hematologic response and survival. [ Time Frame: November 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2002
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Gleevec: Experimental	Drug: Gleevec Starting dose of 400 mg orally daily.

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 8-10 years, or as long as it is judged best to control the leukemia.

Update: January 13, 2009 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 every 2-3 years. 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.

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 M. D. Anderson.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048672

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Jorge E Cortes, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Jorge Cortes M.D./Professor )
Study ID Numbers:	ID01-015
Study First Received:	November 5, 2002
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00048672 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Early Chronic Phase Chronic Myelogenous Leukemia
Leukemia
Gleevec
STI571
Imatinib mesylate

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase

Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 22, 2009