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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

StemEx®

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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