Stem Cell Transplantation with NiCord® for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Mitchell Horwitz, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for patients with certain blood cancers like leukemia or lymphoma who need a stem cell transplant and don't have a fully matched donor. They should be in good enough health to undergo the procedure, not pregnant, without active infections or other cancers, and have a back-up stem cell source.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning Therapy
Participants undergo conditioning therapy to prepare for transplantation
Transplantation
Participants receive either NiCord® or unmanipulated cord blood unit transplantation
Post-transplant Monitoring
Participants are monitored for neutrophil and platelet engraftment and infections
Follow-up
Participants are monitored for safety and effectiveness after transplantation
What Are the Treatments Tested in This Trial?
Interventions
- Cord Blood Unit
- NiCord® (Omidubicel)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gamida Cell ltd
Lead Sponsor