Status:
COMPLETED
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Lead Sponsor:
Mesoblast, Ltd.
Conditions:
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE3
Brief Summary
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
Eligibility Criteria
Inclusion
- Patient must have one of the following:
- Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.
- Hodgkin's disease: High risk subjects with responsive disease after first relapse.
- Minimum Karnofsky Scale
- Subject must weigh at least 20 kg
- Up to 65 years of age
- Adequate major organ system function
Exclusion
- Pregnancy and/or lactating
- Suitable, 6/6 HLA matched related sibling donor available
- Previous participation in a stem cell study within last 30 days
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01854567
Start Date
August 1 2013
End Date
May 5 2017
Last Update
June 26 2020
Active Locations (9)
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1
University of Miami Health System Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065