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)
Condition: Acute Myeloid Leukemia; Advanced Myelodysplastic Syndromes
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Busulfan, Melphalan, Fludarabine, Anti-Thymocyte Globulin, Palifermin, Stem cell transplant
Intervention description: Patients will receive Palifermin 60 mcg/kg/day IV on three consecutive days with the last dose administered no less than 24 and no more than 48 hr prior to start of cytoreduction. The preparative regimen to be used for transplants will consist: of busulfan administered in 12 doses over three days of 0.8 mg/kg IV for patients > or = to 4 years of age or 1.0 mg/kg IV for patients < 4 years of age; melphalan 70 mg/m2 IV x 2 days; and, fludarabine 25 mg/m2 IV x 5 days
Intervention MeSH terms: Fludarabine; Melphalan; Busulfan; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Busulfan; Melphalan; Fludarabine; 08-008

Summary:

      This study will see if the researchers can lower that risk by giving the patient Palifermin.
      This drug helps protect the lining of the mouth, throat, and stomach. These areas typically
      get sores or ulcers while the blood cell counts are very low. The patient can get infections
      in or from these sores. Palifermin might also help the immune system recover faster. It is
      currently approved for patients who receive their own stem cells. That is called an
      autologous transplant. This study will test the use of Palifermin for T-cell depleted
      allogeneic stem cell transplants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients should be < 65 years. Patients > or equal to 65 years will be accrued on a
             case by case basis after discussion and approval by the BMT Service.

          -  Patients may be of either gender or any ethnic background.

          -  Patients must have a Karnofsky or Lansky 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
             benign hyperbilirubinemia.

               -  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 for
                  hemoglobin)

          -  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
             form.

        Exclusion Criteria:

          -  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.