NCT02730299CompletedPhase 3
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
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
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (actual)
- First submitted
- 28 Mar 2016
- Start date
- 16 Dec 2016
- Primary completion date
- 29 Apr 2021
- Lead sponsor
- Gamida Cell ltd
- Diseases
- Acute lymphoblastic leukaemia, Chronic myeloid leukaemia, Myelodysplastic syndromes, Chronic lymphocytic leukaemia, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT02730299
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 125
- From 16 Dec 2016 to the primary completion date, 29 Apr 2021
- 52 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic HSCT
Other illness
- Other active malignancy
- Active or uncontrolled infection
- Active/symptoms of central nervous system (CNS) disease
Other
- HLA-matched donor able to donate
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Israelita Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Sant Joan de Deu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron pediatrics Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| University Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| ICO Bellvitge Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario y Politécnico La Fe (pediatric) Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Robert Debré Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| St James Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Rambam Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center- Beilinson Hospital Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Instituto Português de Oncologia de Lisboa Francisco Gentil Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| National University Cancer Institute Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| The University of Maryland Medicine Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Cleveland Clinic Children's Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Children's Medical Center of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Henry Ford Medical Center Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| West Cancer Clinic Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Loyola University, Cardinal Bernardin Cancer Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Stanford University Cancer Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| UPMC Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.