Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia in Remission
Eligibility Criteria
Inclusion Criteria: The patient must have AML that falls into one of the following categories: AML in 1st complete remission (CR) with intermediate or high risk of relapse following conventional therapy; at least, one of the following features is needed: Patient required more than one cycle of induction to achieve first CR White blood cell count (WBC) > 100,000/mm^3 at diagnosis Any of the following cytogenetic abnormalities: inv (3), t(3:3), del (5q) or -5, 11q23, del(7q) or -7, del (20q) or -20, abnormal 12p, +11 or t8 Any other abnormalities or combination of abnormalities which would predict intermediate or high risk of relapse AML beyond first CR Any patient with an identical twin donor who also meets the criteria above Patients with AML in 1st CR should receive at least two cycles of consolidation chemotherapy prior to mobilization and transplant Patients must have an adequate number of stem cells previously collected (i.e., > 2 x 10^8 total nucleated cell [TNC] of bone marrow [BM]/kg or 4 x 10^6 [CD]34+ PBSC/kg, unless approved otherwise by Dr. Holmberg); prior to stem cell collection patients must be documented to be in remission and to have received two cycles of consolidation therapy after induction therapy Pre-Study tests have been performed Patient must sign an institutional review board (IRB) approved informed consent, conforming with federal and institutional guidelines Exclusion Criteria: Patients with good risk AML defined by cytogenetic evaluation with these abnormalities: inversion 16 or t8;21 Patient's life expectancy is severely limited by diseases other than AML Patient is human immunodeficiency virus (HIV) seropositive Patient is pregnant Patient's creatinine > 2.0 mg/dl Patient's total bilirubin > 2.0 mg/dl (unless Gilbert's disease) Or serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) >= 2.5 x upper limit of normal (ULN) not due to leukemia Patient has a history of congestive heart failure, uncontrolled arrhythmias or left ventricular ejection fraction (LVEF) < 50% Patient has an unrelated human leukocyte antigen (HLA) matched donor and is eligible for a higher priority Fred Hutchinson Cancer Research Center (FHCRC) protocol (for FHCRC patients only) Patient has an HLA matched or one antigen mismatch family donor available Patients with a significant active infection that precludes transplant Patients with a Karnofsky Performance Score less than 70
Sites / Locations
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Experimental
Treatment (chemo, stem cell rescue, interleukin therapy)
PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3. STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0. POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.