This pilot clinical trial studies infusion of expanded cord blood hematopoietic progenitor cells following combination chemotherapy in treating younger patients with acute myeloid leukemia that has relapsed or has not responded to treatment. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy also kills healthy infection-fighting cells, increasing the risk of infection. The infusion of expanded cord blood hematopoietic progenitor cells may be able to replace blood-forming cells that were destroyed by chemotherapy. This cellular therapy may decrease the risk of infection following chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Given IV
Given IV
Given SC or IV
Given IV
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Incidence of NCI CTCAE grade > 3 infusional toxicities
Time frame: Up to 2 years
Occurrence of transfusion associated graft versus host disease
Time frame: Up to 2 years
Incidence of platelet refractoriness in the presence of alloimmunization as a direct result of ex vivo expanded cord blood product infusion
Time frame: Up to 2 years
Incidence of delayed marrow recovery
Failure to achieve ANC \>= 500 cells/µl by day 42 post treatment with marrow cellularity \< 5% and marrow blast count \< 5%.
Time frame: Up to day 42
Rate of treatment related mortality
Time frame: Up to 2 years
Time to neutrophil recovery
ANC \>= 100 cells/ul and 500 cells/ul
Time frame: Up to 2 years
In vivo persistence of ex vivo expanded cellular therapy
Assessed by peripheral blood cell sorted deoxyribonucleic acid (DNA) chimerisms of the cluster of differentiation myeloid and lymphoid cell lineages as well as whole marrow chimerisms.
Time frame: Up to 2 years
Patient and infused expanded cord blood cells immune interaction
Assessed by performing host-donor studies.
Time frame: Up to 2 years
Incidence of NCI CTCAE grade 3 or 4 infections
Time frame: First 30 days following FLAG administration
Incidence of NCI CTCAE grade > 3 chemotherapy-related toxicity in the first 30 days following fludarabine phosphate, cytarabine, and filgrastim (FLAG) therapy
Time frame: First 30 days following FLAG administration
Rate of complete remission
Time frame: Up to 2 years
Leukemia-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
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