Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Chronic Myelogenous Leukemia (CML),Myelodysplastic Syndrome (MDS),Lymphoma,Acute Leukemia,Hematological Malignancies,Acute Lymphoblastic Leukemia (ALL),Acute Myelogenous Leukemia (AML)
Age (in years)
12 - 65
Phase
Phase 3
Participants needed
125
Est. Completion Date
Feb 18, 2025
Treatment type
Interventional
Sponsor
Gamida Cell ltd
ClinicalTrials.gov identifier
NCT02730299
Study number
GC P# 05.01.020
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