Status:
COMPLETED
Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy
Lead Sponsor:
Gamida Cell -Teva Joint Venture Ltd.
Conditions:
Hematologic Malignancies
Acute Myeloid Leukemia
Eligibility:
All Genders
12-55 years
Phase:
PHASE2
PHASE3
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 imp...
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 suita...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00469729
Start Date
October 1 2007
End Date
June 1 2015
Last Update
July 10 2015
Active Locations (30)
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1
UCLA's Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095-1781
2
Children's Hospital of Orange County
Orange, California, United States, 92868-3874
3
The Children's Hospital, B115, University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
4
Northwestern University School of Medicine, Stem Cell Transplant Program, Children's Memorial Hospital
Chicago, Illinois, United States, 60614