A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
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 MDACC
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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