Clinical trial NCT00260065: A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Official title: A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome
Decitabine
Dacogen
MGI Pharma
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.


Eligibility criteria: Inclusion Criteria:

1. Must sign an Institutional Review Board (IRB) -approved informed consent form.
2. Must be 18 years of age or older.
3. Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
4. If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
5. If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.

Exclusion Criteria:

1. Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
2. Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
3. Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
4. Must not have an active viral or bacterial infection.

Primary outcomes:
measure: Number of Participants Who Achieved Overall Response
timeFrame: 1 year
Secondary outcomes:
measure: Best Response and Overall Improvement
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Boca Raton
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Griffin
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Rochester
country: United States
state: Minnesota
city: Hackensack
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Eisai Inc.
name: Eisai US Medical Services
role: STUDY_DIRECTOR
References:
citation: Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
citation: Jabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.