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

This study is currently recruiting participants.
Information provided by Gamida Cell -Teva Joint Venture Ltd.

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Descriptive Information Fields
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
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.
Study Phase Phase II, Phase III
Study Type † Interventional
Study Design † Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure † Overall 100-day mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure † 180 day mortality, acute Graft versus Host Disease (GvHD) grades III-IV, engraftment failure [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Safety and tolerability measures: The incidence and frequency of adverse experiences, acute toxicity, laboratory data and vital signs follow-up. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Condition † Hematologic Malignancies
Acute Myeloid Leukemia
Lymphoid Leukemia
Chronic Myeloid Leukemia
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Myelodysplastic Syndromes
Intervention † Drug: StemEx®
MEDLINE PMIDs 11849228,   15183895,   15160922,   16146887,   16219531
Links Related Info This link exits the ClinicalTrials.gov site
Sponsor's website This link exits the ClinicalTrials.gov site
Study website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 100
Start Date † August 2007
Completion Date November 2010
Eligibility Criteria †

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Clinical diagnosis of HD: induction failure or relapse and sensitive to last chemotherapy course.
  4. Clinical diagnosis of NHL induction failure or relapse and sensitive to last chemotherapy course.
  5. Clinical diagnosis of MDS with intermediate 2- or high-risk IPSS score.

Exclusion Criteria:

  1. Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except Hydroxyurea).
  2. HIV positive.
  3. Pregnancy or lactation.
  4. Uncontrolled bacterial, fungal or viral infection.
  5. Subjects with signs and symptoms of active central nervous system (CNS) disease.
  6. Availability of appropriate related and willing stem cell donor, who is HLA-matched at 5 or 6/6 antigens.
  7. Prior allogeneic cell transplant.
  8. Allergy to bovine or to any product, which may interfere with the treatment.
  9. Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by Sponsor.
Gender Both
Ages 12 Years to 55 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Yael Cohen, MD     972-2-6595666     yaelc@gamida-cell.com    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00469729
Organization ID GC P#02.01.001
Secondary IDs ††
Study Sponsor † Gamida Cell -Teva Joint Venture Ltd.
Collaborators ††
Investigators †
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    
Information Provided By Gamida Cell -Teva Joint Venture Ltd.
Verification Date April 2008
First Received Date † May 3, 2007
Last Updated Date April 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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