Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Hematologic Malignancies

Status:	Withdrawn
Conditions:	Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Anemia, Hematology, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - 65
Updated:	3/15/2019
Start Date:	August 15, 2018
End Date:	August 2021

Infusion of Off the Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (NLA101) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies

This phase II trial studies the effect of ex vivo expanded cord blood progenitor cells
(NLA101) on outcomes from single cord blood transplant for hematologic malignancies. Before
the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some
cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before
a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow,
including normal blood-forming cells (stem cells) and cancer cells. It may also stop the
patient's immune system from rejecting the donor's stem cells. When the healthy stem 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. The donated stem cells may also
replace the patient's immune cells and help destroy any remaining cancer cells. NLA101 is
intended to support neutrophil engraftment and reduce GVHD following transplant.

Key Criteria:

Inclusion Criteria:

- Patient must have hematologic malignancy that meets institutional eligibility
requirements for cord blood transplant

- Malignancies included are:

- Acute leukemia, including acute myeloid leukemia (AML), biphenotypic acute
leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL)

- Myelodysplasia (MDS)

- Chronic Myeloid Leukemia (CML)

- High dose TBI regimen: 18 to =< 45 years

- Intermediate intensity regimen: 18 to =< 65 years

- Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (and non-age adjusted
CI <=5 if >45 years)

- Adequate renal, hepatic, pulmonary, and cardiac function

- Ability to understand and the willingness to sign a written informed consent form

Exclusion Criteria:

- Uncontrolled viral or bacterial infection at the time of study enrollment

- Active or recent (prior 6 month) invasive fungal infection unless cleared by
Infectious Disease (ID) consultant

- History of human immunodeficiency virus (HIV) infection

- Pregnant or breastfeeding

- Prior allogeneic transplant

- Central nervous system (CNS) leukemic involvement not clearing with intrathecal
chemotherapy

We found this trial at

sites

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington 98109

Principal Investigator: Filippo Milano

from

Seattle, WA