Spots Global Cancer Trial Database for Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
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Trial Identification
Brief Title: Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
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
Study ID: NCT02730299
Study Description
Brief Summary: 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.
Detailed Description: Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion. A major drawback of Umbilical Cord Blood (UCB) is the low stem cell dose available for transplantation, compared to mobilized peripheral blood (PB) or bone marrow. This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery, as well as other transplant outcomes. The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation. NiCord® is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of UCB. NiCord® utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of Hematopoietic Progenitor Cells (HPC) expanded in ex vivo cultures. The chief aim of the study is to compare the safety and efficacy of NiCord® single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA, Los Angeles, California, United States
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, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics, São Paulo, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, , Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, São Paulo, , Brazil
Hospital Israelita Albert Einstein, São Paulo, , Brazil
Robert Debré, Paris, , France
Rambam, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Beilinson Hospital, Petach Tikva, , Israel
Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital, Tel HaShomer, , Israel
Careggi University Hospital, Florence, , Italy
Ospedale Pediatrico Bambino Gesù, Rome, , Italy
University Medical Center Utrecht, Utrecht, , Netherlands
Prinses Maxima Centrum voor Kinderoncologie B.V., Utrecht, , Netherlands
Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, , Portugal
National University Cancer Institute, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospital Universitari Vall d'Hebron pediatrics, Barcelona, , Spain
University Hospital Vall d'Hebron, Barcelona, , Spain
ICO Bellvitge, Barcelona, , Spain
Sant Joan de Deu, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Hospital Universitario y Politécnico La Fe (pediatric), Valencia, , Spain
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
St James Hospital, Leeds, , United Kingdom
Manchester University NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Mitchell Horwitz, MD
Affiliation: Duke University
Role: STUDY_CHAIR
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