Chronic Myeloid Leukemia Clinical Trial
Official title:
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)
NCT number | NCT00038675 |
Other study ID # | ID01-167 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2001 |
Est. completion date | November 2013 |
Verified date | December 2021 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Participants 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, Eastern Cooperative Oncology Group (ECOG) performance status < 3, life expectancy > 12 wks, 2. continued from above. Participants 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 included 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, New York Heart Association (NYHA) Class <3. Exclusion Criteria: N/A |
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | Duration of Response | Time from response to disease progression, measuring length of the response in those participants who responded. | 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 | |
Secondary | Overall Survival | Overall survival defined as time from registration to disease progression or death from any cause. | From the start of therapy to death or disease progression, assessed up to 12 years and 5 months |
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