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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195000
• Other study ID #: 0403-762
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 17, 2013
• Start date: May 2003
• Est. completion date: February 2008

Study information

• Verified date: June 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Mylotarg
6 mg/m2 on day 1
• Cytarabine
100 mg/m2 given as continuous infusion daily for 7 days.

Locations

Country	Name	City	State
United States	Weill Medcial College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		From entry until 30 days post treatment.	Yes