Status:
ACTIVE_NOT_RECRUITING
Decitabine in Treating Patients With Myelofibrosis
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Primary Myelofibrosis
Secondary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 marr...
Detailed Description
PRIMARY OBJECTIVES: I. To determine response rate (complete and partial responses and hematological improvement) to decitabine in patients with myelofibrosis. II. To determine the safety of decitabi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00095784
Start Date
September 29 2004
End Date
February 22 2026
Last Update
August 24 2025
Active Locations (14)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
2
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
3
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
4
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426