Leukemia Clinical Trial
Official title:
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncology Group (COG) Study
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that
closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops
the patient's immune system from rejecting the donor's stem cells. The donated stem cells may
replace the patient's immune cells and help destroy any remaining cancer cells
(graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an
immune response against the body's normal cells. Giving antithymocyte globulin before
transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may
stop this from happening.
PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting
leukemia. Bone marrow donors can be selected based on the type of NK cells they have,
specifically the killer immunoglobulin receptor (KIR) type. This study provides information
on KIR type from potential donors, which can be used in selecting the bone marrow donor. This
phase II trial of unrelated donor stem cell transplant in patients with high risk AML
(monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of
the patients and potential donors will be available to the treating transplant physician at
the time of donor selection.
OBJECTIVES:
- To define the relationship between the status of donor NK-cell receptor and patient
outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor (URD)
and umbilical cord blood (UCB) hematopoietic cell transplantation (HCT) in young
patients with acute myeloid leukemia with monosomy 7, -5/5q-, high FLT3 internal tandem
duplication allelic ratio (High-FLT3-ITD AR), or refractory or relapsed acute
myelogenous leukemia.
- To correlate the relationships between factors affecting NK receptor status and clinical
events.
- To assess NK-cell development after URD and UCB HCT in patients with poor prognosis AML.
- To evaluate NK-cell reconstitution and receptor-acquisition pattern in these patients.
OUTLINE: This is a multicenter study.
- Preparative regimen: Patients receive 1 of the following regimens:
- Hematopoietic stem cell transplantation (SCT): Patients receive busulfan IV every 6
hours on days -9 to -6, high-dose cyclophosphamide IV over 1 hour on days -5 to -2,
anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1, and
methylprednisolone IV on days -3 to -1.
- Umbilical cord blood (UCB) transplantation: Conditioning regimen, infusion
procedures, and post-transplant immunoprophylaxis for patients with an UCB donor
are according to institutional guidelines and standards.
- Allogeneic hematopoietic stem cell transplantation (SCT) or umbilical cord blood (UCB)
transplant: Patients undergo allogeneic SCT or UCB transplant on day 0.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine or tacrolimus IV
or orally beginning on day -2 and continuing until day 50, followed by a taper until
week 24. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Blood samples will be collected periodically from both patients and donors for studies of
natural killer cells in support of the study objectives.
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for 3 years.
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