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Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML With PDGF-R Fusion Genes, or Mastocytosis With Imatinib Mesylate (STI571)


N/A
N/A
N/A
Open (Enrolling)
Both
Chronic Myelomonocytic Leukemia, Chronic Myeloid Leukemia, Polycythemia Vera, Hypereosinophilic Syndrome, Mastocytosis

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Trial Information

Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML With PDGF-R Fusion Genes, or Mastocytosis With Imatinib Mesylate (STI571)


Imatinib mesylate is a chemical compound that blocks a protein that is responsible for a
certain form of leukemia. However, imatinib mesylate also blocks other important proteins
that may be responsible for other blood diseases such as myeloproliferative disorders.

Patients in this study will take 4 tablets of imatinib mesylate by mouth every day.
Patients with HES will take 1 tablet daily to begin, and may go up to 4 tablets daily
depending on response. Imatinib mesylate should be taken each morning at breakfast with a
large glass of water. Bottles containing the tablets will be given to the patient every
month. Unused supplies must be returned at the end of the study. Patients taking oral
hydroxyurea to control their blood counts, can continue it during the first month of
imatinib mesylate treatment, but must stop taking it from then on.

After completing 2 months of therapy, response to imatinib mesylate will be evaluated. If
the response is good, treatment with imatinib mesylate alone will be continued. If the
response is not good, the dose of imatinib mesylate will be increased to 8 tablets daily (4
in the morning and 4 in the evening) or may be decreased to 3 tablets daily. This will be
based on how the drug is tolerated. Treatment may be continued for up to one year, or as
long as it is judged best to control the leukemia.

Patients will be asked to visit their doctor for a physical exam and vital signs. The
frequency of doctor visits will vary depending on physical condition.

Blood tests (about 2 teaspoons) will be done once each year. The blood samples will be used
for routine lab tests. A bone marrow sample will also be taken to check and measure cells
related to the disease after 3 - 4 months, then every 3-6 months in the first year. If the
initial bone marrow sample does not show disease, repeated bone marrows will not be done.

This is an investigational study. Imatinib mesylate has been approved in CML for patients
whose disease has not responded to interferon. However, this is an investigational study in
patients with myeloproliferative diseases. The FDA has authorized the use of imatinib
mesylate in research. A total of 145 patients will take part in this study. All will be
enrolled at MD Anderson.


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 included 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

June 2010

Safety Issue:

No

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID01-167

NCT ID:

NCT00038675

Start Date:

June 2001

Completion Date:

June 2015

Related Keywords:

  • Chronic Myelomonocytic Leukemia
  • Chronic Myeloid Leukemia
  • Polycythemia Vera
  • Hypereosinophilic Syndrome
  • Mastocytosis
  • Leukemia
  • Chronic Myelomonocytic Leukemia
  • Chronic Myeloid Leukemia
  • Polycythemia Vera
  • Hypereosinophilic Syndrome
  • Mastocytosis
  • Imatinib Mesylate
  • Gleevec
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma
  • Leukemia, Myelomonocytic, Acute
  • Polycythemia
  • Polycythemia Vera
  • Hypereosinophilic Syndrome

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030