A Phase 2 Study of Fludarabine, cytarabine, Filgrastim and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
The goal of this clinical research study is to learn if idarubicin can be added to the combination of fludarabine, cytarabine, and Neupogen (Filgrastim) without increasing the risk of side effects. This study will also look at whether the addition of idarubicin will increase the long-term chances of patients remaining disease free.
Disease Group: Leukemia
Treatment Agent: ARA-C,Fludarabine,G-CSF,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.
Primary: Evaluate the safety of a regimen incorporating fludarabine, high-dose cytarabine, filgrastim and idarubicin in patients with untreated inv(16) or t(8 21) AML. Evaluate the complete remission rates achieved in this population with this regimen Secondary: Assess the proportion of patients with untreated inv(16) or t(8 21) AML who, having entered CR on this regimen, remain alive in CR two years from CR date Assess whether the quantitative polymerase chain reaction (Q-PCR) results can be used in detecting relapse in these patients.
IRB Review and Approval Date: 04/04/2007
Recruitment Status: Open
Projected Accrual: N/A
1) Patients must have untreated AML, or high-risk MDS [refractory anemia
with excess blasts, (RAEB), or RAEB “in transformation” (RAEB-t)]
characterized by t(8;21), inv(16), or t(16;16).The presence of
additional abnormalities is irrelevant.
2) Age equal to or greater than 18 years (the safety of GO in patients <18 years is not determined and advantage of fludarabine, cytarabine, idarubicin-based regimen in CBF leukemias in children is not demonstrated).
3) Patients must provide written consent.
4) Because of the high possibility of CR in CBF leukemias, participants will not be excluded based on performance status.For patients with Eastern Co-operative Oncology Group (ECOG) performance status >/= to 3 the dosing schedule will be discussed with study chairman.
5) Patients with organ dysfunction will not be excluded from the study. For patients with evidence of organ dysfunction (creatininie >/= 1.5, cardiac ejection fraction </= 50%, total bilirubin >/=2 and AST/ALT >/= 3 times ULN, dose adjustments/omissions will be made.
6) Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of “good-risk” cytogenetics was initially missed. If the patient is in remission from induction therapy, he/she will receive post-remission therapy. If the patient is not in remission then he/she will receive induction therapy.
7) Patients of child bearing potential should practice effective methods of contraception.
1) Pregnant and lactating females will be excluded since the safety of GO or FLAG + Ida in pregnancy and lactation is unknown.For Enrollment:
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