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NCT00095784Active, not recruitingPhase 2

Decitabine in Treating Patients With Myelofibrosis

A Phase II Study of Decitabine in Myelofibrosis

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
21 (actual)
First submitted
9 Nov 2004
Start date
29 Sept 2004
Primary completion date
1 Jul 2008
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT00095784

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 21
  • From 29 Sept 2004 to the primary completion date, 1 Jul 2008
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Maryland/Greenebaum Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Decatur Memorial Hospital
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
NorthShore University HealthSystem-Evanston Hospital
Coordinator of this site? Confirm its status
EvanstonUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Coordinator of this site? Confirm its status
Fort WayneUnited StatesUnknown status
Ingalls Memorial Hospital
Coordinator of this site? Confirm its status
HarveyUnited StatesUnknown status
Loyola University Medical Center
Coordinator of this site? Confirm its status
MaywoodUnited StatesUnknown status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Illinois CancerCare-Peoria
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Oncology Care Associates PLLC
Coordinator of this site? Confirm its status
Saint JosephUnited StatesUnknown status
Northern Indiana Cancer Research Consortium
Coordinator of this site? Confirm its status
South BendUnited StatesUnknown status
Central Illinois Hematology Oncology Center
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.