Clinical Trial

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

Investigator
Complete title:
Infusion of Off the Shelf ex vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel)) in the Setting of Single Cord Blood Transplantation for Patients with Hematologic Malignancies
Trial phase:
Phase II
Study ID:
NCT03399773
Local study ID:
9910
Summary:
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.
Trial keywords:
Leukemia, Leukemia, Myeloid
Enrollment status:
Recruiting
Trial eligibility
Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)

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
Other eligibility criteria may apply.
Trial exclusions
•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 Other exclusion criteria may apply.
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