Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

Korábbi kezelés

• Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.

Más betegség

• Active extramedullary disease
• Active and uncontrolled infection at time of transplantation
• HIV infection

Egyéb

• Pregnant or breast feeding
• Patient is felt to not be a candidate for TBI by the BMT service
  • Donor Inclusion Criteria:
• Donor must be willing and able to undergo PBSC collection.

• Treatment Portion:
• AML in 1st remission - for patients whose AML does not have "good risk" cytogenetic features (i.e. t (8;21), t(15;17), inv 16 without c-kit mutations).
• Acute leukemias of ambiguous lineage in ≥ 1st remission
• Secondary AML in remission
• AML in ≥ 2nd remission
• ALL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL ≥ 2nd remission
• CML failing to respond to or not tolerating imatinib, dasatinib or nilotinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
• Non-Hodgkins lymphoma with chemo responsive disease in any of the following categories:
  • intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
  • b.ii. any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.
• Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2
• Chronic myelomonocytic leukemia: CMML-1 and CMML-2.
• Patient's age is ≥18 or ≤60 years old
• Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status ≥ 70%
• Patients must have adequate organ function measured by:
  • Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must improve with exercise.
• Pulmonary: asymptomatic or if symptomatic, DLCO > 60% of predicted (corrected for hemoglobin)
• Hepatic: < 3xULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
• Renal: serum creatinine < 1.2 mg/dL or if serum creatinine is outside the normal range, the CrCl > 50 ml/min (measured or calculated/estimated)
• Patients have a plan to receive a CD34-selected peripheral blood stem cell transplant with TBI-based conditioning.