Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction Chemotherapy (FLAG) in Patients With Relapsed/Refractory AML
I. Assess the safety of infusing "off-the-shelf" non-human leukocyte antigen (HLA) matched
expanded cord blood cells as supportive care following administration of FLAG (fludarabine
phosphate, cytarabine, and filgrastim) reinduction chemotherapy in pediatric and young adult
patients with relapsed/refractory acute myeloid leukemia (AML).
I. Assess the kinetics of autologous recovery when compared to historical cohorts.
II. Assess the ability of the product to provide transient myeloid engraftment/recovery.
III. Examine the in vivo persistence of the ex vivo expanded cord blood cells by determining
the kinetics and durability of potential engraftment.
IV. Estimate the incidence of clinically significant infections (e.g. bacterial, viral, or
fungal) observed in patients treated with FLAG reinduction chemotherapy followed by
"off-the-shelf" non-HLA matched expanded cord blood cells.
V. Assess the percentage of patients that achieve complete remission (CR)/complete remission
with incomplete blood count recovery (CRi)/complete remission with partial recovery of
platelet count (CRp) with this therapy approach.
VI. Assess long term efficacy (overall survival [OS]/disease free survival [DFS]) of FLAG
reinduction chemotherapy followed by "off-the-shelf" non HLA matched expanded cord blood
cells in pediatric relapsed AML patients during long term follow up.
Patients receive filgrastim subcutaneously (SC) or intravenously (IV) on days 1-7,
fludarabine phosphate IV over 30 minutes on days 2-6, cytarabine IV over 4 hours on days
2-6, and ex vivo-expanded cord blood progenitor cells IV over 30 minutes on day 8.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of grade > 3 infusional toxicity with administration of ex vivo expanded cord blood therapy according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Up to 2 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Emory University||Atlanta, Georgia 30322|