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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195000

Enrollment

Registered

2005-09-19

Start date

2003-05-31

Completion date

2008-02-29

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Keywords

Acute Myeloid Leukemia, Myelodysplastic Syndrome

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

Interventions

DRUGMylotarg

6 mg/m2 on day 1

DRUGCytarabine

100 mg/m2 given as continuous infusion daily for 7 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026