An Open Label Randomized Phase II Study of Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
Inclusion Criteria:
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).
- 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)
- Patients have a plan to receive a peripheral blood stem cell collection.
- Patients must have no change in disease status from treatment eligibility documented
by bone marrow or appropriate imaging within 14 days (bone marrow) or 30 days
(imaging) of transplant
- 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:
1. Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is
congenital benign hyperbilirubinemia.
2. Renal: serum creatinine <1.2 mg/dl or if serum creatinine is outside the normal
range, then CrCl > 50 ml/min (measured or calculated/estimated)
- Patients must receive a peripheral blood stem cell transplant
Exclusion Criteria:
- Active extramedullary disease
- Active and uncontrolled infection at time of transplantation
- Patients who have undergone a prior allogeneic or autologous stem cell transplant
within the previous six months.
- Pregnant or breast feeding
- HIV infection
- 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.