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Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Not Recruiting
Trial ID: NCT02730299
Purpose
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.
Official Title
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
Stanford Investigator(s)
Andrew Rezvani, M.D.
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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
Intervention(s):
other: Cord Blood Unit
drug: NiCord® (omidubicel)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
khanh Nguyen
6507212372