A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML) - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Novartis
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00136409

Purpose

The purpose of this study is to determine the effects (good and bad) of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia.

Condition	Intervention	Phase
Myelofibrosis Myeloid Metaplasia Agnogenic Myeloid Metaplasia Chronic Myelomonocytic Leukemia	Drug: Imatinib mesylate	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Spleen Diseases

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety and efficacy of Gleevec as a single agent in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
to determine the biologic activity of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2002
Study Completion Date:	December 2008
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Intervention Details:

400mg orally once daily until disease progression or unacceptable side effects

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136409

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Novartis

Investigators

Principal Investigator:

Daniel J. DeAngelo, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Daniel DeAngelo, MD, PhD )
Study ID Numbers:	01-214
Study First Received:	August 25, 2005
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00136409 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

myelofibrosis
agnogenic myeloid metaplasia with myelofibrosis
CMML

chronic myelomonocytic leukemia
imatinib mesylate
Gleevec

Study placed in the following topic categories:

Chronic Myelomonocytic Leukemia
Myelofibrosis
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Protein Kinase Inhibitors
Imatinib

Myeloid Metaplasia
Leukemia, Myelomonocytic, Acute
Leukemia
Lymphatic Diseases
Preleukemia
Metaplasia
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Myelodysplastic Myeloproliferative Disease

Additional relevant MeSH terms:

Myelofibrosis
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib

Myeloid Metaplasia
Leukemia, Myelomonocytic, Acute
Leukemia
Lymphatic Diseases
Neoplasms
Pathologic Processes
Therapeutic Uses
Metaplasia
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Splenic Diseases

ClinicalTrials.gov processed this record on July 02, 2009