Acute Myeloid Leukemia Clinical Trial
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Summary
This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.
Full Description
Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion.
A major drawback of Umbilical Cord Blood (UCB) is the low stem cell dose available for transplantation, compared to mobilized peripheral blood (PB) or bone marrow. This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery, as well as other transplant outcomes.
The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation.
NiCord® is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of UCB. NiCord® utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of Hematopoietic Progenitor Cells (HPC) expanded in ex vivo cultures. The chief aim of the study is to compare the safety and efficacy of NiCord® single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy.
Eligibility Criteria
Inclusion Criteria:
Applicable disease criteria
Patients must have one or two partially HLA-matched CBUs
Back-up stem cell source
Adequate Karnofsky/Lansky Performance score
Sufficient physiological reserves
Signed written informed consent
Exclusion Criteria:
HLA-matched donor able to donate
Prior allogeneic HSCT
Other active malignancy
Active or uncontrolled infection
Active/symptoms of central nervous system (CNS) disease
Pregnancy or lactation
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There are 38 Locations for this study
Los Angeles California, 90095, United States
Los Angeles California, 91010, United States
Palo Alto California, , United States
San Diego California, 92093, United States
Denver Colorado, 80045, United States
Evanston Illinois, 60208, United States
Maywood Illinois, 60153, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, , United States
Minneapolis Minnesota, 55455, United States
New Brunswick New Jersey, 08901, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15224, United States
Germantown Tennessee, 38138, United States
Dallas Texas, 75235, United States
Charlottesville Virginia, 22903, United States
Rio De Janeiro , 20230, Brazil
São Paulo , 05403, Brazil
São Paulo , 05403, Brazil
São Paulo , 14048, Brazil
São Paulo , , Brazil
Paris , 75019, France
Haifa , , Israel
Jerusalem , , Israel
Petach Tikva , , Israel
Tel Aviv , , Israel
Tel Aviv , , Israel
Tel HaShomer , , Israel
Florence , 50134, Italy
Rome , 00165, Italy
Utrecht , 3503 , Netherlands
Utrecht , 3584 , Netherlands
Lisbon , 1099-, Portugal
Singapore , 11907, Singapore
Singapore , 16960, Singapore
Barcelona , 08035, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Barcelona , 08950, Spain
Barcelona , , Spain
Sevilla , , Spain
Valencia , 46009, Spain
Valencia , , Spain
Sutton Surrey, SM2 5, United Kingdom
Birmingham , B15 2, United Kingdom
Leeds , LS9 7, United Kingdom
Manchester , M13 9, United Kingdom
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