Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195000
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013

September 13, 2005
June 17, 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. ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
Not Provided

*   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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00195000
0403-762
Not Provided
Eric Feldman, M.D., Weill Cornell Medical College
Weill Medical College of Cornell University
Not Provided
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