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Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195000
First Posted: September 19, 2005
Last Update Posted: June 19, 2013
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.
Information provided by:
Weill Medical College of Cornell University
September 13, 2005
September 19, 2005
June 19, 2013
May 2003
May 2006   (Final data collection date for primary outcome measure)
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. ]
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.
Complete list of historical versions of study NCT00195000 on ClinicalTrials.gov Archive Site
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Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
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
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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Drug: Mylotarg
    6 mg/m2 on day 1
    Other Name: Gemtuzumab Ozogamicin
  • Drug: Cytarabine
    100 mg/m2 given as continuous infusion daily for 7 days.
    Other Name: Ara-C
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2008
May 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00195000
0403-762
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Eric Feldman, M.D., Weill Cornell Medical College
Weill Medical College of Cornell University
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Principal Investigator: Eric Feldman, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP