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A Phase II Study of Decitabine in Myelofibrosis

Phase 2
18 Years
Open (Enrolling)
Primary Myelofibrosis

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Trial Information

A Phase II Study of Decitabine in Myelofibrosis


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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete response, partial response, hematologic improvement)

Outcome Description:

The 95% confidence intervals should be provided.

Outcome Time Frame:

Until relapse or disease progression

Safety Issue:


Principal Investigator

Olatoyosi Odenike

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Primary Myelofibrosis
  • Primary Myelofibrosis



Ingalls Memorial Hospital Harvey, Illinois  60426
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Decatur Memorial Hospital Decatur, Illinois  62526
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Froedtert and the Medical College of Wisconsin Milwaukee, Wisconsin  53226
Evanston CCOP-NorthShore University HealthSystem Evanston, Illinois  60201
Illinois CancerCare-Peoria Peoria, Illinois  61615
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard Fort Wayne, Indiana  46845
Oncology Care Associates PLLC St. Joseph, Michigan  49085
Southern Illinois University Springfield, Illinois  62702