Back to resultsProchymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)
Primary Purpose
Graft-Versus-Host Disease
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Prochymal®
Sponsored by
About this trial
This is an expanded access trial for Graft-Versus-Host Disease focused on measuring GVHD, Prochymal, Graft vs Host Disease
Eligibility Criteria
Inclusion Criteria:
- Patients must be 18 years to 70 years of age, inclusive.
- Biopsy confirmation of GVHD is strongly recommended, to exclude patients presenting with diarrhea or abnormal liver function tests caused by infection.
- Patients must have failed to respond to steroid treatment (methylprednisolone [≥1mg/kg/day] or equivalent) for Grades C-D acute GVHD.
- Prochymal must be administered not longer than 14 days after the initiation of systemic steroid therapy for acute GVHD.
- Prochymal must be administered either before or at the same time any additional GVHD therapy is administered
- Patients must have an adequate renal function as defined by Cockcroft-Gault equation:Calculated creatinine clearance (CrCl) > 30 mL/min
- Patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception.
Exclusion Criteria:
- Patient has stage 3 or 4 liver GVHD, bilirubin >6 mg/dl.
- Patient has stage 4 GI-GVHD.
- Patient has any underlying or current medical condition that would interfere with the evaluation of the patient including uncontrolled infection, sepsis, organ failure, etc or any medical condition that has a high probability of causing death in less than 30 days.
- Patient may not receive any other investigational agent (not approved by the FDA for any indication) concurrently for the duration of the protocol.
- Patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must not be likely to require more than 2 liters of oxygen via face mask or an estimated fractional inspired oxygen concentration (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
- Patient has a known allergy to bovine or porcine products
- Patient has a medical history of a solid tumor disease.
Sites / Locations
- Indiana BMT
- Dana Farber Cancer Institute
- Memorial Sloan Kettering Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00826046
Brief Title
Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)
Official Title
Expanded Access of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mesoblast, Inc.
4. Oversight
5. Study Description
Brief Summary
This protocol allows for the treatment of patients, male and female, between the ages of 18 years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D acute GVHD.
Detailed Description
This is a treatment protocol to provide patients who have failed steroid treatment for acute GVHD expanded access of Prochymal. It is anticipated that a maximum of 10 patients per month for a total of 120 patients per year will be treated according to this protocol.
Patients will be treated with Prochymal twice per week at a dose of 2 x 106 human mesenchymal stem cell (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-Versus-Host Disease
Keywords
GVHD, Prochymal, Graft vs Host Disease
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Prochymal®
Other Intervention Name(s)
Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
Intervention Description
Patients will be treated with Prochymal twice per week at a dose of 2 x 106 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Patients must be 18 years to 70 years of age, inclusive.
Biopsy confirmation of GVHD is strongly recommended, to exclude patients presenting with diarrhea or abnormal liver function tests caused by infection.
Patients must have failed to respond to steroid treatment (methylprednisolone [≥1mg/kg/day] or equivalent) for Grades C-D acute GVHD.
Prochymal must be administered not longer than 14 days after the initiation of systemic steroid therapy for acute GVHD.
Prochymal must be administered either before or at the same time any additional GVHD therapy is administered
Patients must have an adequate renal function as defined by Cockcroft-Gault equation:Calculated creatinine clearance (CrCl) > 30 mL/min
Patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception.
Exclusion Criteria:
Patient has stage 3 or 4 liver GVHD, bilirubin >6 mg/dl.
Patient has stage 4 GI-GVHD.
Patient has any underlying or current medical condition that would interfere with the evaluation of the patient including uncontrolled infection, sepsis, organ failure, etc or any medical condition that has a high probability of causing death in less than 30 days.
Patient may not receive any other investigational agent (not approved by the FDA for any indication) concurrently for the duration of the protocol.
Patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must not be likely to require more than 2 liters of oxygen via face mask or an estimated fractional inspired oxygen concentration (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
Patient has a known allergy to bovine or porcine products
Patient has a medical history of a solid tumor disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahboob Rahman, MD
Organizational Affiliation
Mesoblast, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Indiana BMT
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02284
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)
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