Overview

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

Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Azacitidine
Decitabine
Gemtuzumab
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 involving major organs).

4. Eastern Cooperative Oncology Group (ECOG) performance status of entry.

5. Laboratory test results within these ranges (unless due to leukemia): Serum creatinine
alanine aminotransferase (ALT) (SGPT) 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).