Spots Global Cancer Trial Database for Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy
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Trial Identification
Brief Title: Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy
Official Title: A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx®, Umbilical Cord Blood Stem and Progenitor Cells Expanded Ex Vivo, in Subjects With Hematologic Malignancies Following Myeloablative Therapy
Study ID: NCT00469729
Interventions
Study Description
Brief Summary: The purpose of this study is to determine the efficacy and safety of transplanting StemEx® in patients with certain hematological malignancies. For these patients, it is suggested that StemEx® can improve upon the outcome of transplanting a single, unmanipulated cord blood unit by significantly increasing the number of stem/progenitor cells available to the patient.
Detailed Description: Allogeneic hematopoietic stem cell transplantation is a life-saving procedure for patients with hematologic malignancies; yet wide application of this procedure is limited by the availability of suitably Human Leukocyte Antigen (HLA) - matched donors. Only 30% of patients who could benefit from this procedure have an HLA-matched sibling. The lengthy search for a matched donor may critically delay transplantation. In addition, far fewer patients of racial minorities find suitable HLA-matched donors. Umbilical cord blood (UCB) has been increasingly used as an alternative source of stem cells; however, its use in adults and adolescent patients is limited due to insufficient cell dose required for satisfactory hematopoietic reconstitution. Gamida Cell - Teva Joint Venture Ltd. is engaged in the development of StemEx®, an expanded hematopoietic UCB stem cell graft, as a potential medicinal product for the treatment of cancer and hematological malignancies. The expansion technology enables preferential expansion of hematopoietic stem and early progenitor cells and is based on the findings that copper chelators can regulate the balance between self-renewal and differentiation of stem cells. The multi-national, multi-center Phase II/III clinical study designated to evaluate the safety and efficacy of StemEx® will enroll approximately 100 subjects with high-risk hematologic malignancies who are candidates for allogeneic stem cell transplantation (SCT). This study will evaluate the effect of StemEx® on overall survival as measured by overall 100-day mortality. The study consists of 4 phases: 1. Screening phase includes subjects' clinical assessment and screening tests 2. Conditioning phase includes the myeloablative treatment prior transplantation procedure 3. Transplantation and post-transplant follow-up phase to day 180 4. Observational phase: survival status follow-up to day 730 (18 months)
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA's Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
The Children's Hospital, B115, University of Colorado Health Sciences Center, Aurora, Colorado, United States
Northwestern University School of Medicine, Stem Cell Transplant Program, Children's Memorial Hospital, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center, Loyola University Stritch School of Medicine, Maywood, Illinois, United States
The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Cornell University, Joan & Sanford I. Weill Medical College, New York, New York, United States
Steven and Alexandra Cohen Children's Medical Center of New York, New York, New York, United States
Mount Sinai Medical Center, One Gustave L Levy Place, BOX 1410, New York, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute/UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Texas Transplant Institute, San Antonio, Texas, United States
University of Virginia, Hematopoietic Stem Cell Transplant Program, West Complex 1300 Jefferson Park Av, Charlottesville, Virginia, United States
Medical College of Wisconsin Division of Neoplastic Diseases and Related Disorders, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Pediatric Blood and Marrow Transplant Program, Milwaukee, Wisconsin, United States
Szent Laszlo & Szent Istvan Hospital, Budapest, , Hungary
Hebrew University Hospital Ein-Karem, Department of Bone Marrow Transplantation And Cancer Immunotherapy, Jerusalem, , Israel
Rambam Medical Center, PO Box 9602, Haifa, , Israel
Chaim Sheba Medical Center, Tel Hashomer, , Israel
Ospedale Pedriatrico Bambino Gesù, Roma, , Italy
Universita di Roma Tor Vergata, via Oxford 81, Roma, , Italy
Ospedale di Careggi BMT Unit Department of Haematology, Viale Morgagni, Florence, , Italy
Hospital Clínico Universitario de Valencia, Avda. Blasco Ibañez, 17, Valencia, Comunidad Valenciana, Spain
Hospital Universitario La Fe, Av Campanar 21, Valencia, , Spain
Hospital de la Santa Creu i Sant Pau, C/ Sant Antoni Maria Claret, Barselona, , Spain
Hospital Germans Trias i Pujol, Carretera de Canyet s/n, Badalona, , Spain
Hospital General Universitario Gregorio Marañón, Doctor Esquerdo 46 , Madrid, , Spain
Hospital Universitario Vall d´Hebrón (Pediatrics), Passeig de la Vall d´Hebrón 119-129, Barcelona, , Spain
Hospital Universitario Vall d´Hebrón, Passeig de la Vall d´Hebrón 119-129, Barcelona, , Spain
Contact Details
Name: Ka Wah Chan, MD
Affiliation: Texas Transplant Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Scott D Rowley, MD
Affiliation: The Cancer Center at Hackensack University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Mary Territo, MD
Affiliation: UCLA Oncology Center
Role: PRINCIPAL_INVESTIGATOR
Name: Patrick Stiff, MD
Affiliation: Loyola University Cardinal Bernardin Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Agha Mounzer, MD
Affiliation: University of Pittsburgh Cancer Institute/UPMC Cancer Centers
Role: PRINCIPAL_INVESTIGATOR
Name: Entezam Sahovic, MD
Affiliation: The Western Pennsylvania Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Celia Grosskreutz, MD
Affiliation: Icahn School of Medicine at Mount Sinai
Role: PRINCIPAL_INVESTIGATOR
Name: Roger Giller, MD
Affiliation: The Children's Hospital, B115, University of Colorado Health Sciences Center
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Neudorf, MD
Affiliation: Children's Hospital of Orange County
Role: PRINCIPAL_INVESTIGATOR
Name: Ronit Yerushalmi, MD
Affiliation: Chaim Sheba Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Tsila Zuckerman, MD
Affiliation: Rambam Health Care Campus
Role: PRINCIPAL_INVESTIGATOR
Name: Christelle Ferra, MD
Affiliation: Germans Trias i Pujol Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Cristina Arbona, MD
Affiliation: Hospital Clínico Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Guillermo Sanz, MD
Affiliation: Hospital Universitario La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: William Arcese, MD
Affiliation: Universita di Roma Tor Vergata
Role: PRINCIPAL_INVESTIGATOR
Name: Alberto Bosi, MD
Affiliation: Ospedale di Careggi BMT Unit Department of Haematology
Role: PRINCIPAL_INVESTIGATOR
Name: Sonali Chaudhury, MD
Affiliation: Northwestern University School of Medicine, Stem Cell Transplant Program, Children's Memorial Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Sierra, MD
Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Igor B. Resnick, MD, PhD
Affiliation: Department of Bone Marrow Transplantation And Cancer Immunotherapy Hebrew University Hospital Ein-Karem, Jerusalem
Role: PRINCIPAL_INVESTIGATOR
Name: Prof. Franco Locatelli, MD
Affiliation: Ospedale Pedriatrico Bambino Gesù
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Mi Kwon, MD
Affiliation: Hospital General Universitario Gregorio Marañón
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Pere Barba, MD
Affiliation: Hospital Universitario Vall d´Hebrón
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Cristina Diaz de Heredia, MD
Affiliation: Hospital Universitario Vall d´Hebrón
Role: PRINCIPAL_INVESTIGATOR
Name: Prof. Mary J Laughlin, MD
Affiliation: Hematopoietic Stem Cell Transplant Program, University of Virginia
Role: PRINCIPAL_INVESTIGATOR
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