P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
NCT ID: NCT01854567
Last Updated: 2020-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
49 participants
INTERVENTIONAL
2013-08-31
2017-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Infusion of one MPC expanded cord unit and one unexpanded cord unit
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Control
Infusion of two unexpanded cord blood units.
Infusion of two unexpanded cord blood units.
Umbilical Cord Blood.
Interventions
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Infusion of one MPC expanded cord unit and one unexpanded cord unit
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Infusion of two unexpanded cord blood units.
Umbilical Cord Blood.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Suitable, 6/6 HLA matched related sibling donor available
* Previous participation in a stem cell study within last 30 days
65 Years
ALL
No
Sponsors
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Mesoblast, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Donna Skerrett, MD, MS
Role: STUDY_DIRECTOR
Mesoblast, Ltd.
Elizabeth J. Shpall, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Miami Health System Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell-New York Presbyterian Hospital
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Case Western
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Center at Methodist Healthcare System
San Antonio, Texas, United States
Countries
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Other Identifiers
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2012-0166
Identifier Type: OTHER
Identifier Source: secondary_id
CB-AB006
Identifier Type: -
Identifier Source: org_study_id
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