Status:
UNKNOWN
MAP-guided Preemptive Therapy of aGvHD
Lead Sponsor:
Sichuan University
Conditions:
GVHD,Acute
Stem Cell Transplant Complications
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
Acute graft versus host disease (aGvHD) is a severe and potentially fatal complication of allogeneic hematopoietic stem cell transplantation (HCT). The Mount Sinai Acute GVHD International Consortium ...
Eligibility Criteria
Inclusion
- Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).
- Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
- GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.
- The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
- Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
- ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days prior to enrollment.
- Signed and dated written informed consent obtained from patient or legal representative.
Exclusion
- Patients who develop acute GVHD prior to start of study drug
- Patients at very high risk for relapse post HCT as defined by very high disease risk index
- Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
- Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
- Patients who are pregnant
- Patients on dialysis within 7 days of enrollment
- Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.
- Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of methylprednisolone.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05368181
Start Date
May 1 2022
End Date
December 31 2024
Last Update
May 10 2022
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044