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About
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving interleukin-2 (IL-2, aldesleukin) after transplant may stimulate the natural killer cells to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation followed by interleukin-2 (IL-2, aldesleukin), and umbilical cord blood transplant and to see how well it works in treating patients with relapsed or refractory acute myeloid leukemia.
Full description
OBJECTIVES:
Primary
To determine the rate of neutrophil engraftment and grade III-IV acute graft-versus-host disease (GVHD) following a T cell depleted (TCD) umbilical cord blood (UCB) transplantation without post-transplant immunosuppression followed by administration of interleukin-2 (IL-2, aldesleukin) (every other day) days +3 to +13 to expand NK cells in vivo.
Secondary
To evaluate the safety of this regimen as assessed by monitoring the rates of graft failure, acute GVHD, and transplant-related mortality (TRM). To perform quantitative, phenotypic, and functional assessments of the in vivo expanded UCB-derived NK cells on (day +72). To assess clinical disease response (leukemia clearance and complete remission) and survival duration in these patients. To evaluate the tolerability of aldesleukin in these patients. To evaluate the tolerance of IL-2
OUTLINE:
Preparative regimen: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -7 to -5 and cyclophosphamide IV on days -7 and -6. Patients undergo total-body irradiation twice daily on days -5 to -2. Transplantation: Patients undergo T-cell depleted umbilical cord blood (UCB) transplantation on day 0. IL-2 (Aldesleukin) therapy: Patients receive aldesleukin subcutaneously on days +3 6 doses every other day) and +60 (6 doses every other day).
Patients are followed periodically for up to 2 years after transplant.
Enrollment
Sex
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Inclusion criteria
Aged 0 to 45 years who meet one of the following criteria:
Primary induction failure defined as no complete remission (CR) after two or three induction cycles (no blast limit).
Relapsed acute myeloid leukemia (AML) with low disease burden
CR3 or greater. This will include CRp defined as CR without platelet recovery to 100,000/mcL.
CR1 or CR2 with high risk features (therapy induced, prior myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD), high risk cytogenetic or molecular phenotype) with no available alternate (sibling, URD or UCB) donors.
Patients with prior central nervous system (CNS) involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
Have acceptable organ function within 14 days of enrollment defined as:
Karnofsky score (adults) > 70% or Lansky score > 50% (pediatrics)
Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
All patients will be questioned about prior exposure to antibody therapy (including OKT3, rituximab, trastuzumab, and gemtuzumab) without affect to eligibility. Patients with prior exposure will have a blood sample collected for human anti-mouse antibody (HAMA). For patients with no prior antibody therapy exposure, no further action will be taken.
Not receiving prednisone or other immunosuppressive medications
Voluntary written consent
Exclusion criteria
Criteria for Second Course of IL-2 (begin day +60):
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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