Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy

Completed · Phase 2/Phase 3

Conditions studied: Hematologic Malignancies, Acute Myeloid Leukemia, Lymphoid Leukemia, Chronic Myeloid Leukemia, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT00469729

Run by

Gamida Cell -Teva Joint Venture Ltd.

People needed

101

Starts

2007-10-01

Expected to finish

2015-06-01

Last updated by the study team

2015-07-10

Who can join

Age: 12 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of AML or ALL: CR2 or subsequent complete remission (CR) or CR1 with high-risk features or relapse with < 10% blasts in BM and no circulating blasts.
• Clinical diagnosis of CML: in CP1 (Chronic Phase 1) and resistant or intolerant to Gleevec or in CP2 or subsequent CP or in accelerated phase.
• Clinical diagnosis of HD: induction failure or relapse and sensitive to last chemotherapy course.
• Clinical diagnosis of NHL induction failure or relapse and sensitive to last chemotherapy course.
• Clinical diagnosis of MDS with intermediate 2- or high-risk IPSS score.

You may not qualify if…

• Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except Hydroxyurea).
• HIV positive.
• Pregnancy or lactation.
• Uncontrolled bacterial, fungal or viral infection.
• Subjects with signs and symptoms of active central nervous system (CNS) disease.
• Availability of appropriate related and willing stem cell donor, who is HLA-matched at 5 or 6/6 antigens.
• Prior allogeneic cell transplant.
• Allergy to bovine or to any product, which may interfere with the treatment.
• Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by Sponsor.

Where it is running

• 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 Litwinsky, 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, Valencia, Spain
• Hospital Universitario La Fe — Av Campanar 21, Valencia, Spain

Full record on ClinicalTrials.gov

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