Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00968071

Run by

M.D. Anderson Cancer Center

People needed

71

Starts

2008-02-01

Expected to finish

2012-08-01

Last updated by the study team

2013-03-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Understand and voluntarily sign an informed consent form.
• Age >/= to 16 years at the time of signing the informed consent form.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status of </= to 3 at study entry.
• 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
• 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.

You may not qualify if…

• Pregnant or breastfeeding females.
• Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk.
• Use of any other experimental drug or therapy for leukemia within 7 days unless there is clear evidence of rapid disease progression.
• 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).

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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