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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00037583

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Gemtuzumab Ozogamicin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Primary Purpose:

Treatment

Official Title:

A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)

Actual Primary Completion Date :

Sep 1, 2003

Actual Study Completion Date :

Sep 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts 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