This trial is active, not recruiting.

Condition primary myelofibrosis
Treatment decitabine
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date September 2004
End date July 2008
Trial size 20 participants
Trial identifier NCT00095784, 13327A, CDR0000393839, NCI-2011-01444


This phase II trial is studying how well decitabine works in treating patients with myelofibrosis. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive decitabine subcutaneously on days 1-5 and 8-12.
decitabine 5-aza-dCyd
Given SC

Primary Outcomes

Response rate (complete response, partial response, hematologic improvement)
time frame: Until relapse or disease progression
Incidence of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
time frame: Up to 30 days of last dose of decitabine

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed myeloid metaplasia with myelofibrosis (MMM), including all of the following subtypes: - Chronic idiopathic myelofibrosis - Agnogenic myeloid metaplasia - Post-thrombocythemic myelofibrosis - Post-polycythemic myelofibrosis - Diffuse bone marrow fibrosis - Absence of Philadelphia chromosome OR BCR-ABL rearrangement in peripheral blood cells - Meets 1 of the following criteria: - Anemia (hemoglobin < 11 g/dL) - Palpable splenomegaly* - Morphologic evidence of advanced phase disease, including accelerated phase (10-19% blasts), or evidence of evolution to acute leukemia (≥ 20% blasts) allowed - No known CNS disease - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - No concurrent combination antiretroviral therapy for HIV-positive patients - Bilirubin ≤ 2 mg/dL unless associated with hemolytic anemia as a result of predominantly unconjugated hyperbilirubinemia - AST and ALT ≤ 3 times upper limit of normal (unless due to disease) - Creatinine ≤ 2 mg/dL - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of allergic reaction attributed to compounds of similar chemical or biologic composition to decitabine - No ongoing or active infection - No other uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - At least 2 weeks since prior growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) - No concurrent prophylactic G-CSF or GM-CSF - No concurrent epoetin alfa - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - No prior decitabine - No other concurrent chemotherapy - At least 4 weeks since prior androgenic steroids - No concurrent androgenic steroids - Prior splenic irradiation allowed - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy - Recovered from all prior therapy - At least 4 weeks since other prior therapy - No other concurrent investigational agents - No other concurrent antineoplastic agents

Additional Information

Official title A Phase II Study of Decitabine in Myelofibrosis
Principal investigator Olatoyosi Odenike
Description OBJECTIVES: I. Determine response rate (complete and partial response and hematological improvement) in patients with myeloid metaplasia with myelofibrosis treated with decitabine. II. Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive decitabine subcutaneously on days 1-5 and 8-12. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).