Decitabine in Treating Patients With Myelofibrosis

Running, not enrolling · Phase 2

Conditions studied: Primary Myelofibrosis, Secondary Myelofibrosis

In brief

This phase II trial studies the side effects and how well decitabine works in treating patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar tissue) in the bone marrow that is advanced and for which there is no standard therapy. Decitabine may block the actions of some proteins that are responsible for turning certain genes off in various cancers including myelofibrosis.

Key facts

Study ID

NCT00095784

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2004-09-29

Expected to finish

2027-02-22

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed myeloid metaplasia with myelofibrosis (this includes all subtypes - chronic idiopathic myelofibrosis or angiogenic myeloid metaplasia, post thrombocythemic and post polycythemic myelofibrosis); patients must have anemia (hemoglobin < 11 g/dL) or palpable splenomegaly (measured in cm from costal margin - to be eligible); patients with palpable splenomegaly must have spleen size documented ultrasonographically as well; they must also meet standard diagnostic criteria for MMM
• Patients with morphologic evidence of advanced phases of the disease including accelerated (10-19% blasts) phase or with evidence of evolution to acute leukemia (>= 20% blasts) are also eligible for this study
• The Italian Diagnostic Criteria for MMM
• Necessary criteria
• Diffuse bone marrow fibrosis
• Absence of the Philadelphia chromosome or BCR-ABL rearrangement in peripheral blood cells
• Optional criteria
• Splenomegaly of any grade
• Anisopoikilocytosis with tear drop erythrocytes
• Presence of circulating immature myeloid cells
• Presence of circulating erythroblasts
• Presence of clusters of megakaryoblasts and anomalous megakaryocytes in bone marrow sections
• Myeloid metaplasia
• Diagnosis of MMM is acceptable if the following combinations are present
• The two necessary criteria plus any other two optional criteria when splenomegaly is present OR
• The two necessary criteria plus any other four optional criteria when splenomegaly is absent
• Patients may have had prior chemotherapy or radiation therapy including splenic irradiation; prior therapy with erythropoietin, granulocyte-colony stimulating factor (GCSF), other growth factors or androgenic steroids is also permitted; there is no limit to the number of prior regimens received; at least 4 weeks must have elapsed since prior chemo or radiation therapy; at least 2 weeks must have elapsed since growth factor (erythropoietin, GCSF, granulocyte-macrophage colony-stimulating factor [GM-CSF]) or other therapy
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Total bilirubin =< 2mg/dL
• In patients with associated hemolytic anemia; total bilirubin > 2mg/dL is permissible as long as this is as a result of predominantly unconjugated hyperbilirubinemia; such patients may be enrolled only after discussion with the study chair
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal unless due to disease
• Serum creatinine =< 2mg/dL
• Patients must not be pregnant or nursing; women of child- bearing potential and men must agree to use an effective contraceptive method; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Prior therapy with decitabine
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents
• Patients with known central nervous system (CNS) disease should be excluded from this clinical trial
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with decitabine
• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Oncology Care Associates PLLC — Saint Joseph, Michigan, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.