Phase 3
Completed N=125
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Hematological Malignancies · Acute Lymphoblastic Leukemia (ALL) · Acute Myelogenous Leukemia (AML) · Chronic Myelogenous Leukemia (CML)
Source: ClinicalTrials.gov NCT02730299 ↗
Enrolled (actual)
125
Serious AEs
90.7%
Results posted
Oct 2022
Primary outcomePrimary: Time to Neutrophil Engraftment — 12; 22 days
◆ Published Evidence
Highly cited
109citations · ~22 / year
Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study.
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.
Linked Publications (4)
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Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study.
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Immune Reconstitution Profiling Suggests Antiviral Protection after Transplantation with Omidubicel: A Phase 3 Substudy.
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Hospitalization and Healthcare Resource Utilization of Omidubicel-Onlv versus Umbilical Cord Blood Transplantation for Hematologic Malignancies: Secondary Analysis from a Pivotal Phase 3 Clinical Trial.
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47th Annual Meeting of the EBMT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Neutrophil Engraftment |
12; 22 | — |
| SECONDARY First Grade 2/3 Bacterial or Invasive Fungal Infections by 100 Days Following Transplantation |
24; 38 | — |
| SECONDARY Days Alive and Out of Hospital in the First 100 Days Post-transplantation |
60.5; 48 | — |
| SECONDARY Number of Participants With Platelet Engraftment by 42 Days Post-transplantation |
34; 22 | — |
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
Data sourced from ClinicalTrials.gov (NCT02730299) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.