Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037596

Enrollment

Unknown

Registered

2002-05-20

Start date

2000-08-31

Completion date

2003-04-30

Last updated

2013-02-13

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

Conditions

Acute Myeloid Leukemia

Brief summary

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

Interventions

DRUGGemtuzumab Ozogamicin

DRUGcytarabine.

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Morphologic diagnosis of AML from bone marrow aspirate and biopsy * Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria * Age 18 years or older for relapsed or refractory patients for Phase I of this study

Exclusion criteria

* Patients with de novo AML of the M3 subtype * AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of \> 2 months duration * AML secondary to exposure to chemotherapy or radiation

Outcome results

None listed

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