Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine; Gemtuzumab Ozogamicin
Intervention description: 20 mg/m^2 IV over an hour and half daily for 5 days.; 3 mg/m^2 IV on day 5.
Intervention MeSH terms: Decitabine; Gemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Leukemia; AML; MDS; High-Risk Myelodysplastic Syndrome; Decitabine; 5-aza-2 deoxycytidine; Dacogen; Gemtuzumab Ozogamicin; Mylotarg

Summary:

      The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine
      (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or
      high-risk MDS. The safety of this drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age >/= to 16 years at the time of signing the informed consent form.

          3. Diagnosis of Acute myeloid leukemia (AML) [other than acute promyelocytic leukemia
             (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be
             eligible if not a candidate for intensive chemotherapy. Patients with high-risk
             Intermediate-2 or high by International Prognostic Scoring System (IPSS) or >/= to 10%
             blasts) MDS will also be eligible. All non-hematological toxicity of previous cancer
             therapy should have resolved to </= grade 1 (except alopecia or other toxicities not
             involving major organs).

          4. Eastern Cooperative Oncology Group (ECOG) performance status of </= to 3 at study
             entry.

          5. Laboratory test results within these ranges (unless due to leukemia): Serum creatinine
             </= 2 mg/dL Total bilirubin </= 2 mg/dL aspartate aminotransferase (AST) (SGOT) and/or
             alanine aminotransferase (ALT) (SGPT) </= 2.5 x ULN or </= 5 times Upper limit of
             normal (ULN) if related to disease

          6. Women of childbearing potential (WCBP) must have a negative urine pregnancy test
             within 7 days and must either commit to continued abstinence from heterosexual
             intercourse or adopting at least one highly effective method of contraception. These
             methods include intra-uterine device, tubal ligation, partner's vasectomy, hormonal
             birth control pills. Men must agree not to father a child and agree to use a condom if
             his partner is of child bearing potential.

        Exclusion Criteria:

          1. Pregnant or breastfeeding females.

          2. Any condition, including the presence of laboratory abnormalities, which places the
             patient at unacceptable risk.

          3. Use of any other experimental drug or therapy for leukemia within 7 days unless there
             is clear evidence of rapid disease progression.

          4. Use of hydrea to control proliferative disease will be allowed prior to starting
             therapy on study and for up to 7 days each during cycle 1-3 (Maximum daily dose of
             7gm).