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Study Summary
No. ID01-167:.......Leukemia......Jorge Cortes......Leukemia
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Study Summary Title
Study Summary
Number:		ID01-167
Study Title:Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Imatinib Mesylate (STI571)
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Physician New Patient Referral
Name:Jorge CortesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5783
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:N/AReturn
Visit:		Every 3 months
Treatment
Agents:		GleevecHome Care:Patients will take own medications at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None anticipated
Description/
Intervention:		The goal of this clinical research study is to see if Gleevec, known as
imatinib mesylate (STI571), can improve the disease condition in patients with
hypereosinophilic syndrome, polycythemia vera, atypical CML or CMML with PDGF-R
fusion genes, or mastocytosis.
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Study Objectives / Outcomes
Primary Objectives:
To determine the objective response rate in patients with Hypereosinophilic syndrome (HES), polycythemia vera (PV), atypical CML or CMML with PDGF-R fusion genes, and mastocytosis.
Secondary Objectives:
To evaluate duration of response and survival.
To investigate evidence of clonality in patients with PV and correlation with any possible response to imatinib in this subgroup of patients.
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Study Status Information
Study Activation / Registration Date:06/11/2001
IRB Review and Approval Date:05/02/2001
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Pts must have 1 of the following hematopoietic malignancies: Hypereosinophilic syndrome (HES), Polycythemia vera (PV), Atypical CML or CMML with PDGF-R fusion genes, Mastocytosis, Serum bilirubin less than 2 mg%, serum creatinine less than 2 mg% unless abnormality is considered due to hematologic malignancy by investigator, ECOG performance status < 3, life expectancy > 12 wks,

2) continued from above. Pts must sign informed consent indicating they are aware of the investigational nature of the study, in keeping with policies of the hospital, women of pregnancy potential must practice birth control. 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. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be incuded in this protocol as they are referred in the relevant populations.

3) continued from above. There are no exclusions of women or minorities based on the study objectives, NYHA Class <3.
Exclusion Criteria:N/A
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Links
Registration Number: NCT000038675
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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