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

Completed · Phase 3

Conditions studied: Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndrome (MDS), Lymphoma, Acute Leukemia

In brief

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.

Key facts

Study ID

NCT02730299

Run by

Gamida Cell ltd

People needed

125

Starts

2016-12-16

Expected to finish

2025-02-07

Last updated by the study team

2026-02-25

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Los Angeles, California, United States
• Stanford University Cancer Institute — Palo Alto, California, United States
• UC San Diego Moores Cancer Center — San Diego, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Northwestern University — Evanston, Illinois, United States
• Loyola University, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• The University of Maryland Medicine Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Children's — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• West Cancer Clinic — Germantown, Tennessee, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA — Rio de Janeiro, Rio de Janeiro, Brazil
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics — São Paulo, São Paulo, Brazil
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, São Paulo, Brazil
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo — São Paulo, São Paulo, Brazil
• UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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