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)
Phase 2
18 Years
59 Years
18 Years
59 Years
Not Enrolling
Both
Acute Myeloid Leukemia
Both
Acute Myeloid Leukemia
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
0903B1-206
NCT ID:
NCT00037583
Start Date:
Completion Date:
September 2003
Related Keywords:
- Acute Myeloid Leukemia
- Acute
- Myeloid
- Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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