Back to resultsEfficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
Primary Purpose
Graft Vs Host Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
UC-MSC
Anti-CD25 mAb
Sponsored by
About this trial
This is an interventional treatment trial for Graft Vs Host Disease
Eligibility Criteria
Inclusion Criteria:
- 1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent.
Exclusion Criteria:
- 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.
6. Patients who are deemed unsuitable for the study by the investigator.
Sites / Locations
- Peking University Insititute of Hematology, Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UC-MSC and anti-CD25 mAb
Anti-CD25 mAb
Arm Description
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment.
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after first 4 weeks of treatment.
Outcomes
Primary Outcome Measures
Rate of complete remission
Complete remission of aGVHD related symptoms and indicators
Secondary Outcome Measures
Overall survival
The time from randomization to death for any reason ( the last follow-up time for missing patients; end date of follow-up for patients who are live at the end of the study).
Rate of partial remission
improvement of aGVHD staging in one or more organs without progression in other organs
Infusion toxicity
Acute toxicity responses include impaired function of heart, kidney and liver
Full Information
NCT ID
NCT04738981
First Posted
February 1, 2021
Last Updated
May 31, 2023
Sponsor
Peking University People's Hospital
Collaborators
Southern Medical University, China, Third Military Medical University, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04738981
Brief Title
Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
Official Title
Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Southern Medical University, China, Third Military Medical University, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.
Detailed Description
A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25 monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate after 4 weeks of treatment in the two groups will be compared. Adverse events are also recorded throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Vs Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UC-MSC and anti-CD25 mAb
Arm Type
Experimental
Arm Description
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment.
Arm Title
Anti-CD25 mAb
Arm Type
Active Comparator
Arm Description
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after first 4 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
UC-MSC
Other Intervention Name(s)
Umbilical cord-derived mesenchymal stem cells
Intervention Description
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Anti-CD25 mAb
Other Intervention Name(s)
Basiliximab
Intervention Description
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Primary Outcome Measure Information:
Title
Rate of complete remission
Description
Complete remission of aGVHD related symptoms and indicators
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time from randomization to death for any reason ( the last follow-up time for missing patients; end date of follow-up for patients who are live at the end of the study).
Time Frame
At the end of Week 4 / 8 / 12 / 24 / 52.
Title
Rate of partial remission
Description
improvement of aGVHD staging in one or more organs without progression in other organs
Time Frame
4 weeks after treatment
Title
Infusion toxicity
Description
Acute toxicity responses include impaired function of heart, kidney and liver
Time Frame
From the beginning of to four hours after every infusion of UC-MSC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent.
Exclusion Criteria:
- 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.
6. Patients who are deemed unsuitable for the study by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Zhang, doctor
Organizational Affiliation
Peking University People's Hospital, Peking University Insititute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Insititute of Hematology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
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