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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

0903B1-205

NCT ID:

NCT00037596

Start Date:

August 2000

Completion Date:

April 2003

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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