- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00968071
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome
A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Study Overview
Status
Intervention / Treatment
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 is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive decitabine through a needle in your vein over 1 and 1/2 hours on Days 1-5 of each cycle. You will also receive gemtuzumab ozogamicin by vein over about 1 hour after you receive decitabine on Day 5 of each 4-6 week cycle.
During Cycle 1 only, if a bone marrow test done 2 weeks after you receive your first study drug treatment shows abnormal leukemia cells, you will receive another treatment with decitabine intravenously over 1 and 1/2 hours for 5 days.
Gemtuzumab may cause allergic reactions, nausea, and vomiting. To help prevent such side effects, you will receive Benadryl (diphenhydramine) and hydrocortisone. You may receive these drugs by vein, or by mouth on the days you get gemtuzumab ozogamicin during the entire study.
Study Visits:
During Cycle 1, blood (about 2 teaspoons) will be drawn at least 1 time each week for routine tests. If the doctor thinks it is necessary, you may be asked to have additional blood drawn.
During Cycle 1, after approximately 2 weeks of your first study drug administration , you will have a bone marrow aspiration to decide whether you will receive additional decitabine in Cycle 1.
During Cycles 2-3, blood (about 2 teaspoons) will be drawn for routine tests at least 2 times each month.
During Cycles 4 and beyond, blood (about 2 teaspoons) will be drawn for routine tests at least 1 time each month.
If the doctor thinks it is necessary, you may have a bone marrow aspirate every 1 to 3 months to check the status of the disease.
Length of Study:
You may receive the combination of decitabine and gemtuzumab ozogamicin for up to 6 cycles. After this, if your doctor thinks it is in your best interest, you may continue to take decitabine alone for up to 24 cycles. You will be taken off study early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to receive the study drug(s).
Long-term Follow-up:
Once you are off study, you will have follow up visits every month for up to 2 years. At these visits, blood (about 2 teaspoons) will be drawn for routine tests.
This is an investigational study. Gemtuzumab ozogamicin is FDA approved and commercially available for the treatment of AML that has come back after treatment in patients over the age of 65 years. Decitabine is FDA approved and commercially available for the treatment of MDS. The use of gemtuzumab ozogamicin and decitabine in combination is investigational.
Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
20 mg/m^2 IV over an hour and half daily for 5 days.
Other Names:
3 mg/m^2 IV on day 5.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 36 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gautam Borthakur, MBBS, UT MD Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Decitabine
- Gemtuzumab
Other Study ID Numbers
- 2007-0882
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myelodysplastic Syndrome
-
Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.CompletedPreviously Treated Myelodysplastic Syndrome | Myelodysplastic Syndrome | Therapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic Syndrome | Refractory High Risk Myelodysplastic SyndromeUnited States
-
Thomas Jefferson UniversityAbbVieRecruitingMyelodysplastic Syndrome | Recurrent Myelodysplastic Syndrome | Refractory Myelodysplastic SyndromeUnited States
-
TJ Biopharma Co., Ltd.Recruiting
-
National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RecruitingMyelodysplastic Syndromes (MDS)United States, Israel
-
AbbVieCelgene; Genentech, Inc.CompletedMyelodysplastic Syndromes (MDS)United States, Australia, Germany
-
AbbVieGenentech, Inc.Active, not recruitingMyelodysplastic Syndromes (MDS)United States, Australia, Canada, France, Germany, Italy, United Kingdom
-
The First Affiliated Hospital with Nanjing Medical...UnknownMyelodysplastic Syndromes (MDS)China
-
Uma BorateRecruitingTherapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic SyndromeUnited States
-
University Hospital, BrestRecruitingMyelodysplastic Syndromes | Myelodysplastic Syndrome With Isolated Del(5Q) | Myelodysplastic Syndrome With Del(5Q)France
-
Cyclacel Pharmaceuticals, Inc.SuspendedLeukemia | Myelodysplastic Syndrome(MDS)United States
Clinical Trials on Decitabine
-
Otsuka Beijing Research InstituteRecruitingMyelodysplastic SyndromesChina
-
Chinese PLA General HospitalRecruitingHodgkin Lymphoma | Anti-PD-1 Antibody ResistantChina
-
Astex Pharmaceuticals, Inc.CompletedAcute Myeloid Leukemia | Myelodysplastic Syndromes | Chronic Myelomonocytic LeukemiaUnited States, Canada, Spain, Hungary, Austria, Czechia, France, Germany, Italy, United Kingdom
-
M.D. Anderson Cancer CenterGenentech, Inc.; Astex Pharmaceuticals, Inc.RecruitingChronic Myelomonocytic Leukemia | Myelodysplastic SyndromeUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkRecruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterRecruitingAcute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent Acute Biphenotypic Leukemia | Refractory Acute Biphenotypic LeukemiaUnited States
-
Shandong UniversityUnknownMyelodysplastic SyndromesChina
-
Eisai Inc.TerminatedMyelodysplastic SyndromesUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Astex Pharmaceuticals, Inc.RecruitingChronic Phase Chronic Myelogenous Leukemia | Philadelphia Chromosome Positive | BCR-ABL1 Positive Chronic Myelogenous Leukemia | BCR-ABL1 PositiveUnited States