Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
NCT ID: NCT00759018
Last Updated: 2020-03-09
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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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Patients will be treated with Prochymal twice per week at a dose of 2 x 10\^6 hematopoietic stem cells (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
Conditions
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Interventions
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remestemcel-L
Patients will be treated with Prochymal® twice per week at a dose of 2 x 10\^6 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Since patients being treated with Prochymal® under this protocol are under 18, a parental signature of informed consent will be required.
* Patients must be 2 months to 17 years of age, inclusive.
* Patients must have failed to respond to steroid treatment for Grades B-D acute GVHD • Failure to respond to steroid treatment for acute GVHD is defined as any Grade B-D acute GVHD that is not improving after at least 3 days of methylprednisolone (≥1 milligram per kilogram per day \[mg/kg/day\]) or equivalent.
Exclusion Criteria
* Patient must not have received a transplant for a solid tumor disease.
* Patients must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must be unlikely to require more than 2 liters (L) of oxygen via face mask or an estimated fraction of inspired oxygen (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
2 Months
17 Years
ALL
No
Sponsors
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Mesoblast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mahboob Rahman
Role: STUDY_DIRECTOR
Mesoblast, Inc.
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF
San Francisco, California, United States
Children's National
Washington D.C., District of Columbia, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Childrens Memorial
Chicago, Illinois, United States
James Witcomb Riley Hosptial for Children
Indianapolis, Indiana, United States
LSU Health Science Center/Children's Hospital
New Orleans, Louisiana, United States
Wayne State University/Childrens' Hospital
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Doernbecher Children's Hospital (OHSU)
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Texas Childrens Hospital
Houston, Texas, United States
Methodist Childrens Hospital of South Texas
San Antonio, Texas, United States
Massey Cancer Center
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Countries
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References
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Kurtzberg J, Prockop S, Chaudhury S, Horn B, Nemecek E, Prasad V, Satwani P, Teira P, Hayes J, Burke E; MSB-275 Study Group. Study 275: Updated Expanded Access Program for Remestemcel-L in Steroid-Refractory Acute Graft-versus-Host Disease in Children. Biol Blood Marrow Transplant. 2020 May;26(5):855-864. doi: 10.1016/j.bbmt.2020.01.026. Epub 2020 Feb 7.
Other Identifiers
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275
Identifier Type: -
Identifier Source: org_study_id
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