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Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02652130
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : March 16, 2022
Last Update Posted : March 16, 2022
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Grade B Acute Graft Versus Host Disease Grade C Acute Graft Versus Host Disease Grade D Acute Graft Versus Host Disease Biological: Remestemcel-L Phase 3

Detailed Description:
This is a safety follow-up study through 180 days of remestemcel-L treatment in participants who took part in MSB-GVHD001. This study will also explore duration of response over time. Participants who took part in in MSB-GVHD001 and received at least one dose of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 for safety endpoints. Participants who took part in Protocol MSB-GVHD001 and received the first 8 doses of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 after initial remestemcel-L infusion for evidence of duration of response over time.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 28, 2015
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Safety population
All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001.
 Biological: Remestemcel-L
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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival Rate Through Day 180 [ Time Frame: From Baseline Day 1 in the Study MSB-GVHD001 up to Day 180 in Study MSB-GVHD002 (180 days) ]
    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.


Secondary Outcome Measures :
  1. Overall Survival Rate at Day 180 for Participants Who Had Overall Response (OR) at Day 28 of Study MSB-GVHD001 [ Time Frame: From Baseline (Day 1) in the Study MSB-GVHD001 up to Day 180 in the Study MSB-GVHD002 (180 days) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652130


Locations
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Sponsors and Collaborators
Mesoblast, Inc.
Quintiles, Inc.
Investigators
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Study Director: Christopher James Mesoblast, Inc.
  Study Documents (Full-Text)

Documents provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
Study Protocol and Statistical Analysis Plan  [PDF] July 10, 2018

More Information
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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT02652130    
Other Study ID Numbers: MSB-GVHD002
First Posted: January 11, 2016    Key Record Dates
Results First Posted: March 16, 2022
Last Update Posted: March 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
GVHD
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Remestemcel-l
 Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents