Status:
COMPLETED
A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD
Lead Sponsor:
John Levine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft-versus-host-disease
GVHD
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication. The researchers have developed a blood test to identify patients most ...
Eligibility Criteria
Inclusion
- High risk prediction score as determined by the Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm at either day 7 or day 14 post Hematopoietic cell transplant (HCT).
- Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood).
- Donor and recipient match each other for at least 7/8 HLA-loci (HLA-A, B, C, and DR)
- Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
- GVHD prophylaxis must include a calcineurin inhibitor combined with methotrexate or mycophenolate.
- 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 alpha-1-antitrypsin.
- History of allergic reaction to alpha-1-antitrypsin
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03459040
Start Date
August 17 2018
End Date
August 21 2020
Last Update
July 12 2021
Active Locations (5)
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1
City of Hope
Duarte, California, United States, 91010
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Ohio State University
Columbus, Ohio, United States, 43210