Back to resultsMylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Primary Purpose
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mylotarg
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Myelodysplastic Syndrome
Eligibility Criteria
Inclusion Criteria: Histologic diagnosis of AML or advanced MDS No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C). Exclusion Criteria: Uncontrolled or severe cardiovascular disease or pulmonary disease
Sites / Locations
- Weill Medcial College of Cornell University
Outcomes
Primary Outcome Measures
To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.
Secondary Outcome Measures
Full Information
NCT ID
NCT00195000
First Posted
September 13, 2005
Last Updated
June 17, 2013
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00195000
Brief Title
Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Official Title
Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years.
Detailed Description
To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.
Patients eligible for treatment will receive the following:
Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion
Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Keywords
Acute Myeloid Leukemia, Myelodysplastic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Mylotarg
Other Intervention Name(s)
Gemtuzumab Ozogamicin
Intervention Description
6 mg/m2 on day 1
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-C
Intervention Description
100 mg/m2 given as continuous infusion daily for 7 days.
Primary Outcome Measure Information:
Title
To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.
Time Frame
From entry until 30 days post treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of AML or advanced MDS
No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C).
Exclusion Criteria:
Uncontrolled or severe cardiovascular disease or pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Feldman, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medcial College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
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Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
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