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Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec - Article


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Chronic Fatigue Immune Dysfunction Syndrome




Clinical Trial: Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec

This study is currently recruiting patients.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center

Purpose

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.

Condition Treatment or Intervention Phase
Chronic Myelomonocytic Leukemia
Chronic Myeloid Leukemia
Polycythemia Vera
Hypereosinophilic Syndrome
Mastocytosis
 Drug: Gleevec (imatinib mesylate)
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Bone Marrow Diseases;   Cancer;   Cancer Alternative Therapy;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Skin Diseases

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title: Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec (STI571)

Further Study Details: 

Expected Total Enrollment:  100

Study start: June 2001

To date, 25 patients with myeloproliferative syndromes have been included in this study. Five of 9 patients with HES have responded. The efficacy of Gleevec in HES has been confirmed in at least one other study. We have also treated 5 patients with PV and two of them have experienced a reduction in the need for transfusions and at least two others have reported symptomatic improvement. A beneficial effect from Gleevec has been observed also by other investigators. Responses in mastocytosis have been reported recently in 4 of 9 patients treated. In addition, patients with atypical CML or CMML with PDGF-R fusion genes have been reported to have significant activity with imatinib. We have not identified any clinical activity in other disease categories originally included on this study. Thus, we plan to continue accrual only in the following groups: ­ HES ­ Atypical CML or CMML with PDGF-R fusion genes ­ PV ­ Mastocytosis

Eligibility

Genders Eligible for Study:  Both

Criteria

Patients must meet the following eligibility criteria:

  • Patients must have one of the following hematopoietic malignancies: a. Hypereosinophilic syndrome (HES) b. Polycythemia vera (PV) c. Atypical CML or CMML with PDGF-R fusion genes d. Mastocytosis
  • Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is considered due to hematologic malignancy by investigator.
  • ECOG Performance Status < 3. Life expectancy > 12 weeks.
  • Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the 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. There are no exclusions of women or minorities based on the study objectives.
  • NYHA Class < 3.

Location and Contact Information


Texas
      M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Jorge E Cortes, MD  713-794-5783    jcortes@mdanderson.org 
Hagop M Kantarjian, MD  713-792-7026    hkantarj@mdanderson.org 
Jorge E Cortes, MD,  Principal Investigator
Hagop M Kantarjian, MD,  Sub-Investigator

More Information

Study ID Numbers:  ID01-167
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  June 4, 2002
ClinicalTrials.gov Identifier:  NCT00038675
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 2, 2008



Page Updated: September 6, 2005
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