A Phase II Trial of Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
- Patients should be < 65 years. There is no lower age limit. Patients > or equal to 65
years will be accrued on a case by case basis after discussion and approval by the
- Patients may be of either gender or any ethnic background.
- Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status > or
equal to 70%.
- Patients must have adequate organ function measured by:
* Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > or equal to 50%
and must improve with exercise.
- Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital
- Renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is
outside the normal range, then CrCl > 60-ml/min/1.73 m2
- Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected
- Each patient must be willing to participate as a research subject and must sign an
informed consent form.
- Parent or legal guardians of patients who are minors will sign the informed consent
- Active CNS or skin leukemic involvement
- Female patients who are pregnant or breast-feeding
- Active viral, bacterial or fungal infection
- Patient seropositive for HIV-I/II; HTLV -I/II
- Patients who have undergone a prior allogeneic or autologous stem cell transplant
within the previous six months.
- Patients who have had a previous malignancy that is not in remission.
- Patients with known hypersensitivity to mouse proteins (murine antibodies in ISOLEX)
if receiving PBSC or bovine proteins if receiving SBA-E- bone marrow, or chicken egg