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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037583

Enrollment

Registered

2002-05-20

Start date

Unknown

Completion date

2003-09-30

Last updated

2009-08-21

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

Conditions

Acute Myeloid Leukemia

Keywords

Acute, Myeloid, Leukemia

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.

Interventions

DRUGGemtuzumab Ozogamicin

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026