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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Alpha-1-Proteinase Inhibitor Human in Preventing Development of Steroid-Refractory Graft Versus Host Disease in Stem Cell Transplant Participants

This phase II trial studies the side effects and how well alpha-1-proteinase inhibitor human works in preventing development of graft versus host disease in stem cell transplant participants. Graft versus host disease is the most common serious complication after receiving a bone marrow transplant. Alpha-1-proteinase inhibitor human may help prevent the inflammatory immune response from graft versus host disease and damage to the skin, liver, stomach, and / or intestines.
Not Available
Pilot
Adults
Not Available
Not Available
Jagasia, Madan
National
Vanderbilt University
09-11-2018
Prevention
VICCBMT1833
NCT03459040

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

High risk prediction score as determined by the Mount Sinai Acute Graft Versus Host Disease (GVHD) International Consortium (MAGIC) algorithm at either day 7 or day 14 post hematopoietic stem cell transplantation (HCT).

Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood).

Related and unrelated donor and recipient match each other for at least 7/8 human leukocyte antigen (HLA)-loci (HLA-A, B, C, and D-related [DR]).

Cord blood donor(s) match recipient for at least 4/6 HLA-loci (HLA A, B, and DR).

Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.

Any GVHD prophylaxis is permitted.

The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted.

Direct bilirubin must be
Within 3 days prior to enrollment: alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) and aspartate aminotransferase (AST)/Serum Glutamic Oxaloacetic Transaminase (SGOT) must be
Signed and dated written informed consent obtained from patient or legal representative.



Exclusion Criteria:

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% fraction of inspired oxygen (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.

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