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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968071
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 safety of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome Drug: Decitabine Drug: Gemtuzumab Ozogamicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Study Start Date : February 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: Decitabine + Gemtuzumab Ozogamicin
Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days, Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
Drug: Decitabine
20 mg/m^2 IV over an hour and half daily for 5 days.
Other Name: Dacogen

Drug: Gemtuzumab Ozogamicin
3 mg/m^2 IV on day 5.
Other Names:
  • Gemtuzumab
  • Mylotarg

Primary Outcome Measures :
  1. Number of Participants With Complete Response (CR) [ Time Frame: Up to 36 weeks ]
    Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral anc >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00968071

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Gautam Borthakur, MBBS UT MD Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00968071    
Other Study ID Numbers: 2007-0882
First Posted: August 28, 2009    Key Record Dates
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013
Last Verified: February 2013
Keywords provided by M.D. Anderson Cancer Center:
High-Risk Myelodysplastic Syndrome
5-aza-2 deoxycytidine
Gemtuzumab Ozogamicin
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Antineoplastic Agents, Immunological