Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00968071
First received: August 26, 2009
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: Decitabine Drug: Gemtuzumab Ozogamicin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Participants With Complete Response (CR) [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 71 |
| Study Start Date: | February 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968071
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Gautam Borthakur, MBBS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968071 History of Changes |
| Other Study ID Numbers: | 2007-0882 |
| Study First Received: | August 26, 2009 |
| Results First Received: | February 4, 2013 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia AML MDS High-Risk Myelodysplastic Syndrome Decitabine |
5-aza-2 deoxycytidine Dacogen Gemtuzumab Ozogamicin Mylotarg |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Decitabine Gemtuzumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013