Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

Wyeth

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Gemtuzumab Ozogamicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037583

0903B1-206

Details and patient eligibility

About

The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.

Enrollment: 69 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
• Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
• Phase II will only allow enrollment of younger de novo AML

Exclusion criteria

• AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
• De novo patients with M3 AML
• AML secondary to exposure to chemotherapy or radiation