Status:
COMPLETED
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 saf...
Detailed Description
The Study Drugs: Gemtuzumab ozogamicin is designed to attach to Sialic acid-binding Ig-like lectin 3 (CD33), a certain protein that is often found in leukemia cells, causing them to die. Decitabine ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00968071
Start Date
February 1 2008
End Date
August 1 2012
Last Update
March 8 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030