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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mylotarg

6 mg/m2 on day 1

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

Other Intervention Names

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Gemtuzumab Ozogamicin Ara-C

Eligibility Criteria

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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).