Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Safety Follow-up Through 180 Days of Treatment With Remestemcel-L in Study MSB-GVHD001 in Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
1 other identifier
interventional
32
1 country
20
Brief Summary
Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with systemic corticosteroid therapy.
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 Oct 2015
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2015
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedResults Posted
Study results publicly available
March 16, 2022
CompletedMarch 16, 2022
February 1, 2022
2.6 years
November 3, 2015
December 1, 2021
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival Rate Through Day 180
The overall survival rate is defined as the percentage of participants alive at the given time point. OS is defined as the time to death from the start of drug therapy.
From Baseline Day 1 in the Study MSB-GVHD001 up to Day 180 in Study MSB-GVHD002 (180 days)
Secondary Outcomes (1)
Overall Survival Rate at Day 180 for Participants Who Had Overall Response (OR) at Day 28 of Study MSB-GVHD001
From Baseline (Day 1) in the Study MSB-GVHD001 up to Day 180 in the Study MSB-GVHD002 (180 days)
Study Arms (1)
Safety population
EXPERIMENTALAll participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001.
Interventions
No intervention was given in Study MSB-GVHD002 (NCT02652130). It was a safety follow-up trial of remestemcel-L-treated participants from Study MSB-GVHD001.
Eligibility Criteria
You may qualify if:
- Participants must have participated in MSB-GVHD001 and have received at least one infusion of remestemcel-L.
- Participant or participant's authorized representative must be capable of providing written informed consent. Assent, if applicable, must also be collected when required by the Institutional Review Board (IRB)/Ethics Committee (EC).
- Female participants of childbearing potential (≥ 10 years of age) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- The participant must be willing and able to comply with study procedures, remain at the clinic as required during the study period, and return to the clinic for the follow-up evaluation as specified in this protocol.
You may not qualify if:
- The investigator believes it to be in the best interest of the participant not to participate in the safety follow-up study.
- Participant has participated or is currently participating in any autologous or allogeneic stem cell or gene therapy study for the treatment of aGVHD. Participants participating in investigative protocols aimed at modification of the transplant graft (such as T cell depletion) or aimed at modification of the conditioning regimen will be allowed in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
- Quintiles, Inc.collaborator
Study Sites (20)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
CHOC Children's Hospital of Orange County
Orange, California, 92868, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94143, United States
Children's Hospital Colorado Center for Cancer/Blood Disorders
Aurora, Colorado, 80045, United States
Alfred I. duPont Hospital for Children of the Nemours Foundation
Wilmington, Delaware, 19803, United States
Miami Children's Research Institute
Miami, Florida, 33155, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10174, United States
The Children's Hospital at Montefiore
New York, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Christopher James, VP, Head of Clinical Operations
- Organization
- Mesoblast, Inc.
Study Officials
- STUDY DIRECTOR
Christopher James
Mesoblast, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
January 11, 2016
Study Start
October 28, 2015
Primary Completion
June 15, 2018
Study Completion
June 15, 2018
Last Updated
March 16, 2022
Results First Posted
March 16, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share