A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim, Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
ARA-C, Fludarabine, G-CSF, Gemtuzumab Ozogamicin, Idarubicin
The goal of this clinical research study is to learn if gemtuzumab ozogamicin and idarubicin can be added to the combination of fludarabine, cytarabine, and Filgrastim-sndz without increasing the risk of side effects. This study will also look at whether the addition of gemtuzumab ozogamicin and idarubicin will increase the long-term chances of patients remaining disease free.
Disease Group: Leukemia
Treatment Agent: ARA-C, Fludarabine, G-CSF, Gemtuzumab Ozogamicin, Idarubicin
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: Patients will be admitted for the duration of induction chemotherapy. Patients ;over the age of 50 years will be given the option of staying in the "protected ;environment" for the approximately 4 weeks of induction to remission.
Return Visit: Once a month for approximately 7 months
Home Care: Supportive care that includes blood transfusions, antibiotics or growth factors ;including G-CSF as per protocol can be administered by local oncologist. ;Patients can be instructed to self-administer G-CSF.
IRB Review and Approval Date: 04/04/2007
Recruitment Status: Open
Projected Accrual: N/A
Information and next steps
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