Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML With Platelet Derived Growth Factor (PDGF-R) Fusion Genes, or Mastocytosis With Imatinib Mesylate (STI571)
Sponsor study identifier
interventional
125
1 country
1
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
June 4, 2002
Actual (reported)June 5, 2002
Actual (reported)November 2013
Actual (reported)November 2013
Actual (reported)January 4, 2022
Actual (reported)Number of Participants With a Complete Response (CR)
Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood \& bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, \& platelet count \>100 x 10\^9/L; or CR marrow=As per CR but platelet count \< 100 x 10\^9/L. Agnogenic myeloid metaplasia (AMM) \& CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10\^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (\< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\</=10%), disappearance signs/symptoms of disease. Mastocytosis: CR=disappearance of mast cell infiltrates in affected organs, decrease of serum tyrptase levels to \<20 ng/ml, \& disappearance of SM-associated organomegaly.
after 2 months of therapy, up to 1 year.
Duration of Response
From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months
Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily.
Imatinib mesylate 400 mg orally daily, and in HES patients start with imatinib mesylate 100 mg orally daily
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Jorge Cortes, MD
UT MD Anderson Cancer Center
125 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2002
First Posted
June 5, 2002
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Overall Survival
From the start of therapy to death or disease progression, assessed up to 12 years and 5 months
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
January 4, 2022
Results First Posted
January 4, 2022
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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