Back to resultsP3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Primary Purpose
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Infusion of one MPC expanded cord unit and one unexpanded cord unit
Infusion of two unexpanded cord blood units.
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Cord Blood, Stem Cells, MPC, Mesoblast, Expanded, AML, ALL, NHL, Leukemia, Lymphoma
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- Pregnancy and/or lactating
- Suitable, 6/6 HLA matched related sibling donor available
- Previous participation in a stem cell study within last 30 days
Sites / Locations
- University of Miami Health System Sylvester Comprehensive Cancer Center
- Moffitt Cancer Center
- Beth Israel Deaconess Medical Center
- Memorial Sloan Kettering Cancer Center
- Weill Cornell-New York Presbyterian Hospital
- Westchester Medical Center
- Case Western
- MD Anderson Cancer Center
- Texas Transplant Center at Methodist Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active
Control
Arm Description
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Infusion of two unexpanded cord blood units.
Outcomes
Primary Outcome Measures
Time to Neutrophil and Platelet Engraftment
Secondary Outcome Measures
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
Percentage of patients with primary graft failure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01854567
Brief Title
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
September 23, 2016 (Actual)
Study Completion Date
May 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mesoblast, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease
Keywords
Cord Blood, Stem Cells, MPC, Mesoblast, Expanded, AML, ALL, NHL, Leukemia, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Infusion of two unexpanded cord blood units.
Intervention Type
Biological
Intervention Name(s)
Infusion of one MPC expanded cord unit and one unexpanded cord unit
Intervention Description
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Intervention Type
Biological
Intervention Name(s)
Infusion of two unexpanded cord blood units.
Intervention Description
Umbilical Cord Blood.
Primary Outcome Measure Information:
Title
Time to Neutrophil and Platelet Engraftment
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
Time Frame
100 days
Title
Percentage of patients with primary graft failure
Time Frame
100 days
Other Pre-specified Outcome Measures:
Title
Incidence and severity of acute Graft Versus Host Disease
Time Frame
100 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Pregnancy and/or lactating
Suitable, 6/6 HLA matched related sibling donor available
Previous participation in a stem cell study within last 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Skerrett, MD, MS
Organizational Affiliation
Mesoblast, Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth J. Shpall, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Health System Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Case Western
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Transplant Center at Methodist Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
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