P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment
2 other identifiers
interventional
49
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2013
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2017
CompletedJune 26, 2020
June 1, 2020
3.1 years
May 13, 2013
June 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Neutrophil and Platelet Engraftment
100 days
Secondary Outcomes (2)
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
100 days
Percentage of patients with primary graft failure
100 days
Other Outcomes (1)
Incidence and severity of acute Graft Versus Host Disease
100 days
Study Arms (2)
Active
EXPERIMENTALInfusion of one MPC expanded cord unit and one unexpanded cord unit.
Control
ACTIVE COMPARATORInfusion of two unexpanded cord blood units.
Interventions
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy and/or lactating
- Suitable, 6/6 HLA matched related sibling donor available
- Previous participation in a stem cell study within last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Ltd.lead
Study Sites (9)
University of Miami Health System Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell-New York Presbyterian Hospital
New York, New York, 10065, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Case Western
Cleveland, Ohio, 44106, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Transplant Center at Methodist Healthcare System
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Donna Skerrett, MD, MS
Mesoblast, Ltd.
- PRINCIPAL INVESTIGATOR
Elizabeth J. Shpall, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 15, 2013
Study Start
August 1, 2013
Primary Completion
September 23, 2016
Study Completion
May 5, 2017
Last Updated
June 26, 2020
Record last verified: 2020-06