Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, childhood myelodysplastic syndromes, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Myelodysplastic syndromes
Disease meets 1 of the following criteria:
- In first complete remission (CR)
- In second CR
- In relapse
- No more than 50% blasts in bone marrow
- Not deemed eligible for standard transplantation regimens by the attending physician, or at high risk for relapse
- No suspected or proven CNS leukemia
- HLA-matched (6/6) sibling donor available
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Glomerular filtration rate (pediatric patients) or creatinine clearance ≥ 60 mL/min OR serum creatinine < 1.5 times upper limit of normal (ULN)
- Serum bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times ULN
- LVEF ≥ 50% by ECHO or MUGA scan
- DLCO or FEV_1 ≥ 40% predicted
- Not pregnant
- Negative pregnancy test
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing, active, or poorly controlled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Poorly controlled pulmonary disease
- Psychiatric illness/social situation that would limit compliance with study requirement
- No active cytomegalovirus (CMV) or fungal disease
- HIV negative
PRIOR CONCURRENT THERAPY:
- Recovered from prior intensive chemotherapy (pediatric patients)
- At least 100 days since prior autologous stem cell transplantation
- At least 100 days since prior radiotherapy administered as part of a transplantation conditioning regimen
- At least 4 weeks since prior chemotherapy
- At least 24 hours since prior hydroxyurea for blast count control
Sites / Locations
- City of Hope Comprehensive Cancer Center