Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

Trial ID or NCT#

NCT02730299

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 12 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

khanh Nguyen
6507212372

View on ClinicalTrials.gov