Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)
Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
1 other identifier
interventional
43
1 country
1
Brief Summary
The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety of this drug combination will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
April 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
August 9, 2013
CompletedSeptember 13, 2013
September 1, 2013
3.3 years
April 15, 2009
June 6, 2013
September 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With a Complete Response
Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral absolute neutrophil count (ANC) \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).
Day 14 of first cycle
Study Arms (1)
Decitabine + Gemtuzumab Ozogamicin
EXPERIMENTALDecitabine 20 mg/m\^2 by vein (IV) over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m\^2 by vein on day 5.
Interventions
Decitabine 20 mg/m\^2 IV over 1-1/2 hours daily for 5 days.
Gemtuzumab ozogamicin 3 mg/m\^2 IV on day 5.
Eligibility Criteria
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 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 \>/= 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 \</=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 \* upper limit of normal (ULN) or \</= 5 \* 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:
- For patients with MF only: Diagnosis of MF requiring therapy, including those previously treated by MF-directed therapy and relapsed or refractory; or if newly diagnosed then with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: hemoglobin (Hb) \< 10 g/dl, White blood cells (WBC) \< 4 or \> 30 \* 10\^9/L; risk group: 0 = low, 1 = intermediate, 2 = high), or with symptomatic splenomegaly (\>/=10cm below left mid-costal margin).
- For patients with MF only: Performance status 0-2 (Zubrod).
- For patients with MF only: Signed informed consent.
- For patients with MF only: Patients must have been off MF-directed therapy for 2 weeks prior to entering this study and have recovered from the toxic effects (grade 0-1) of that therapy. Patients are allowed to enter the study if on stable dose, for at least 1 months, of anagrelide (to control high platelets) or hydroxyurea (to control high WBC or enlarging spleen), or on stable dose, for at least 2 months, of erythropoietin (for significant anemia).
- For patients with MF only: Serum bilirubin levels \</= 2 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis, as judged by treating physician.
- For patients with MF only: Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) levels \</= 2\* ULN, unless related to the MF, as judged by treating physician.
- For patients with MF only: Serum creatinine levels \</= 2\* ULN.
- For patients with MF only: Women of childbearing potential must have a negative serum pregnancy test prior to treatment and should be advised to avoid becoming pregnant. Men must be advised to not father a child while receiving treatment. Both women of childbearing potential and men must practice effective methods of contraception (those generally accepted as standard of care measures).
- For patients with MF only: Age \> 18 years.
- 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 14 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 7 gm).
- For patients with MF only: Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- For patients with MF only: Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Eisai Inc.collaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gautam Borthakur, MD/Associate Professor
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gautam Borthakur, M.D.
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2009
First Posted
April 16, 2009
Study Start
April 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 13, 2013
Results First Posted
August 9, 2013
Record last verified: 2013-09