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A Phase II Study of Gleevec (Imatinib Mesylate) In Patients With BCR-Negative Myeloproliferative Disorders Including Patients With Idiopathic Myelofibrosis With Myeloid Dysplasia or Chronic Myelomonocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelofibrosis, Myeloid Metaplasia, Agnogenic Myeloid Metaplasia, Chronic Myelomonocytic Leukemia

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Trial Information

A Phase II Study of Gleevec (Imatinib Mesylate) In Patients With BCR-Negative Myeloproliferative Disorders Including Patients With Idiopathic Myelofibrosis With Myeloid Dysplasia or Chronic Myelomonocytic Leukemia


Gleevec will be administered at a dose of 400 mg orally once daily.

Patients will continue to receive the drug until either drug progression or the development
of intolerable side effects.

Patients will be assessed with a complete blood count weekly for the first 8 weeks and will
have monthly physical examinations and bone marrow examinations every 3 months.


Inclusion Criteria:



- Patients must have a clinical diagnosis of myelofibrosis with myeloid metaplasia or
chronic myelomonocytic leukemia (CMML). Patients may be entered based on a prior
cytogenetic karyotype showing the absence of the Philadelphia chromosome.

- Patients may be entered prior to completion of reverse transcription-polymerase chain
reaction (RT-PCR) or fluorescent in situ hybridization (FISH) studies, but a patient
who is subsequently found to be BCR-ABL or FISH positive will be removed from
protocol treatment. FISH will only be performed on patients with a normal karyotype.
A PCR sample will be sent on all patients.

- The patients with myelodysplasia must have French-American-British (FAB) subtype
chronic myelomonocytic leukemia (CMML) defined as peripheral blood monocytosis, and
less than 30 percent blasts in the peripheral blood or the bone marrow.

- The patients with myelofibrosis with myeloid metaplasia can have one of the
following: agnogenic myeloid metaplasia (idiopathic myelofibrosis), or
post-polycythemic myeloid metaplasia (post-polycythemic myelofibrosis), or
post-thrombocythemic myeloid metaplasia.

- Estimated life expectancy of 6 months or greater.

- Serum bilirubin equal to or less than twice the upper limit of normal.

- Serum SGOT and SGPT equal to or less than twice the upper limit of normal.

- Serum creatinine equal to or less than twice the upper limit of normal.

- Age at least 18 years.

- Greater than 4 weeks from any chemotherapy (except hydroxyurea), radiotherapy,
immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal
therapy is allowed). Systemic glucocorticoid therapy for non-malignant disease is
allowed.

- The last dose of hydroxyurea must be 24 hours prior to the initiation of Gleevec.

- Greater than 2 months following bone marrow or peripheral blood stem cell
transplantation or treatment with donor lymphocyte infusion (DLI).

Exclusion Criteria:

- Uncontrolled active infection.

- Pregnancy or nursing mothers.

- Patients with myelofibrosis with myeloid metaplasia or chronic myelomonocytic
leukemia who have transformed to acute myelogenous leukemia.

- Prior treatment or diagnosis of acute myelogenous leukemia.

- Patients with Philadelphia positive cytogenetics by either peripheral blood or bone
marrow sampling.

- Eastern Cooperative Oncology Group (ECOG) performance status > 3.

- Prior exposure to Gleevec.

- Active central nervous system (CNS) disease.

- Evidence of infection with the human immunodeficiency virus.

- Active psychiatric or mental illness making informed consent or careful clinical
follow-up unlikely.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the overall response rate of Gleevec as a single agent in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Daniel J. DeAngelo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

01-214

NCT ID:

NCT00136409

Start Date:

May 2002

Completion Date:

December 2008

Related Keywords:

  • Myelofibrosis
  • Myeloid Metaplasia
  • Agnogenic Myeloid Metaplasia
  • Chronic Myelomonocytic Leukemia
  • myelofibrosis
  • agnogenic myeloid metaplasia with myelofibrosis
  • CMML
  • chronic myelomonocytic leukemia
  • imatinib mesylate
  • Gleevec
  • Primary Myelofibrosis
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Metaplasia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617