Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
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| ClinicalTrials.gov Identifier: NCT04738981 |
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Recruitment Status :
Not yet recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
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Sponsor:
Peking University People's Hospital
Collaborators:
Southern Medical University, China
Third Military Medical University
Sun Yat-sen University
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Graft Vs Host Disease | Drug: UC-MSC Drug: Anti-CD25 mAb | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial |
| Estimated Study Start Date : | February 2021 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Basiliximab
| Arm | Intervention/treatment |
|---|---|
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Experimental: UC-MSC and anti-CD25 mAb
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.
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Drug: UC-MSC
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks.
Other Name: Umbilical cord-derived mesenchymal stem cells Drug: Anti-CD25 mAb Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Other Name: Basiliximab |
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Active Comparator: Anti-CD25 mAb
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.
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Drug: Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Other Name: Basiliximab |
Primary Outcome Measures :
- Rate of complete remission [ Time Frame: 4 weeks after treatment ]Complete remission of aGVHD related symptoms and indicators
Secondary Outcome Measures :
- Overall survival [ Time Frame: At the end of Week 4 / 8 / 12 / 24 / 52. ]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 [ Time Frame: 4 weeks after treatment ]improvement of aGVHD staging in one or more organs without progression in other organs
- Infusion toxicity [ Time Frame: From the beginning of to four hours after every infusion of UC-MSC ]Acute toxicity responses include impaired function of heart, kidney and liver
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT04738981
Contacts
| Contact: Xiaohui Zhang, doctor | +8613522338836 | zhangxh100@sina.com | |
| Contact: Xueyan Sun, doctor | +8615625074109 | ssnowyan@163.com |
Locations
| China, Beijing | |
| Peking University Insititute of Hematology, Peking University People's Hospital | |
| Beijing, Beijing, China, 100010 | |
Sponsors and Collaborators
Peking University People's Hospital
Southern Medical University, China
Third Military Medical University
Sun Yat-sen University
Investigators
| Principal Investigator: | Xiaohui Zhang, doctor | Peking University People's Hospital, Peking University Insititute of Hematology |
| Responsible Party: | Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital |
| ClinicalTrials.gov Identifier: | NCT04738981 |
| Other Study ID Numbers: |
GVHD-PKU2021 |
| First Posted: | February 4, 2021 Key Record Dates |
| Last Update Posted: | February 4, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Graft vs Host Disease Immune System Diseases Basiliximab |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |