Could a chemo drug help patients with rare bone marrow cancer?
NCT ID NCT00095784
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This phase II trial tests the drug decitabine in 21 patients with advanced myelofibrosis, a bone marrow cancer that causes scarring and anemia. The goal is to see if decitabine can improve blood counts and reduce the need for transfusions. Researchers are also monitoring side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Decitabine (a chemotherapy drug)
- What this could lead to
- If it works, this could offer a treatment option for patients with advanced myelofibrosis who have no standard therapy.
- What could go wrong
- This is a small, early-phase trial with only 21 participants. The drug may cause side effects and may not improve outcomes for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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21 people
The number who actually took part.
- Started
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Sep 2004
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702, United States
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Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
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Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
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Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
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Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
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Loyola University Medical Center
Maywood, Illinois, 60153, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
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Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
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Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
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