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

Wyeth is now a wholly owned subsidiary of Pfizer69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Gemtuzumab OzogamicinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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