Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Gamida Cell -Teva Joint Venture Ltd. |
---|---|
Information provided by: | Gamida Cell -Teva Joint Venture Ltd. |
ClinicalTrials.gov Identifier: | NCT00469729 |
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.
Condition | Intervention | Phase |
---|---|---|
Hematologic Malignancies Acute Myeloid Leukemia Lymphoid Leukemia Chronic Myeloid Leukemia Hodgkin's Disease Non-Hodgkin's Lymphoma Myelodysplastic Syndromes |
Drug: StemEx® |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 12 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Snyder, PhD | 972-2-6595666 | David.snyder@gamida-cell.com |
Principal Investigator: | Elizabeth J Shpall, MD | M.D. Anderson Cancer Center |
Principal Investigator: | Ka Wah Chan, MD | Texas Transplant Institute |
Principal Investigator: | Mary J Laughlin, MD | Case Western Reserve University |
Principal Investigator: | Scott D Rowley, MD | The Cancer Center at Hackensack University Medical Center |
Principal Investigator: | Mary Territo, MD | UCLA Oncology Center |
Principal Investigator: | Joanne Kurtzberg, MD | Duke University |
Principal Investigator: | Patrick Stiff, MD | Loyola University Cardinal Bernardin Cancer Center |
Principal Investigator: | Agha Mounzer, MD | University of Pittsburgh Cancer Institute/UPMC Cancer Centers |
Principal Investigator: | Entezam Sahovic, MD | The Western Pennsylvania Hospital |
Principal Investigator: | Monica Bhatia, MD | Columbia University College of Physicians and Surgeons |
Principal Investigator: | Celia Grosskreutz, MD | Mount Sinai School of Medicine |
Principal Investigator: | Roger Giller, MD | The Children's Hospital, B115, University of Colorado Health Sciences Center |
Principal Investigator: | William Tse, MD | University of Colorado Cancer Center, University of Colorado Denver Health Science Center |
Principal Investigator: | Steven Neudorf, MD | Children’s Hospital of Orange County |
Principal Investigator: | Ronit Yerushalmi, MD | Chaim Sheba Medical Center |
Principal Investigator: | Tsila Zuckerman, MD | Rambam Health Care Campus |
Principal Investigator: | Christelle Ferra, MD | Hospital Germans Trias i Pujol |
Principal Investigator: | Enric Carreras, MD | Hospital Clinic of Barcelona |
Principal Investigator: | Cristina Arbona, MD | University of Valencia |
Principal Investigator: | Guillermo Sanz, MD | Hospital Universitario La Fe |
Principal Investigator: | William Arcese, MD | Universita di Roma Tor Vergata |
Principal Investigator: | Alberto Bosi, MD | Ospedale di Careggi BMT Unit Department of Haematology |
Principal Investigator: | Gerard Socie, MD | Hopital Saint Louis |
Principal Investigator: | Sonali Chaudhury, MD | Northwestern University School of Medicine, Stem Cell Transplant Program, Children's Memorial Hospital |
Principal Investigator: | Jorge Sierra, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Principal Investigator: | Dr. Tamas Masszi, MD | Szent Laszlo and Szent Istvan Hospital |
Responsible Party: | Gamida Cell - Teva Joint Venture Ltd. ( Dr. David Snyder ) |
Study ID Numbers: | GC P#02.01.001 |
Study First Received: | May 3, 2007 |
Last Updated: | January 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00469729 |
Health Authority: | United States: Food and Drug Administration |
Tetraethylenepentamine Umbilical Cord Blood Stem Cell Transplantation Hematological Malignancies Acute Lymphoid Leukemia Subjects with high-risk hematologic malignancies who are candidates for allogeneic stem cell transplantation |
Leukemia, Lymphoid Hodgkin's disease Hematologic Neoplasms Precancerous Conditions Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Leukemia, Myeloid, Acute Leukemia Preleukemia Hodgkin Disease Lymphoma Acute myelocytic leukemia Myelodysplastic syndromes |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Bone Marrow Diseases |
Neoplasms Neoplasms by Site Pathologic Processes Disease |
Neoplasms by Histologic Type Immune System Diseases Syndrome |