An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine
Intervention description: Decitabine 20 mg per m^2 will be administered intravenous infusion over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 5-aza-2'-deoxycytidine; decitabine; dacogen; Myelodysplastic Syndrome

Summary:

      The purpose of this study is to evaluate the response rate of decitabine in previously
      treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease
      associated with decreased production of blood cells, blood cells are produced but do not
      mature normally).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with documented pathological (bone marrow, no longer than 30 days before
             first dosing in study) evidence of Myelodysplastic syndromes (MDS) or of chronic
             myelomonocytic leukemia (CMML) by World health organisation classification

          -  Participants with international prognostic scoring system (IPSS) score equal to 0.5 or
             more (only for participants for whom IPSS is applicable)

          -  Participants with an Eastern oncology cooperative group (ECOG) performance status of
             0-2

          -  Participants with adequate hepatic (liver) and renal (kidney) function as measured by
             pre-treatment laboratory criteria within 21 days of starting treatment with decitabine

          -  Participants must have recovered from toxic effects of previous therapy and not
             receiving any chemotherapy for a minimum of 4 weeks (6 weeks if the participants has
             been treated with a nitrosoureas) before to the first dose of study drug

        Exclusion Criteria:

          -  Participants with a diagnosis of acute myeloid leukemia (AML) (greater than 30 percent
             bone marrow blasts)

          -  Participants with AML with multilineage dysplasia (abnormal development or cell
             growth) following MDS (20-30 percent bone marrow blasts) can be enrolled. For these
             latter participants an observation period of 1 month is necessary to exclude those
             participants with rapid progression to full blown AML

          -  Participants with previous treatment with azacitadine or decitabine or hematopoietic
             stem cell transplantation less than 1 year prior to study enrollment

          -  Participants with past history of malignancy and received any treatment for this
             before malignancy within the last 3 years, except for superficial bladder cancer,
             basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia
             (CIN) or prostate intraepithelial neoplasia (PIN)

          -  Participants with known hepatitis B (surface antigen-positive) or active hepatitis C
             infection