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

• ClinicalTrials.gov Identifier: NCT00136409
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Last Update Posted: December 23, 2016
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital; Novartis
• Information provided by (Responsible Party): Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: August 25, 2005
• First Posted Date: August 29, 2005
• Last Update Posted Date: December 23, 2016
• Study Start Date: May 2002
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 20, 2007): 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 ]
• Original Primary Outcome Measures (submitted: August 25, 2005): 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.

Current Secondary Outcome Measures (submitted: December 20, 2007)

• 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 ]
• 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 ]

Original Secondary Outcome Measures (submitted: August 25, 2005)

• 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
• to determine the biologic activity of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)
• 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
• Brief Summary: 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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Myelofibrosis
• Myeloid Metaplasia
• Agnogenic Myeloid Metaplasia
• Chronic Myelomonocytic Leukemia

Intervention

Drug: Imatinib mesylate

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

Other Name: Gleevec

Study Arms

Experimental: Mono-Therapy Gleevec

Gleevec administered orally at a pre-determined dose once daily.

Intervention: Drug: Imatinib mesylate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2016): 34
• Original Enrollment (submitted: August 25, 2005): 60
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00136409
• Other Study ID Numbers: 01-214
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
• Study Sponsor: Dana-Farber Cancer Institute

Collaborators

• Brigham and Women's Hospital
• Massachusetts General Hospital
• Novartis

Investigators

• Principal Investigator: Daniel J. DeAngelo, MD, PhD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: December 2016