Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Trial ID or NCT#
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.
A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies
- - 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
- - 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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