CompletedNot Applicable

α1-antitrypsin (AAT) Levels and Functions in Allogeneic Bone Marrow Transplantation and Throughout Progression Into GVHD

Israel27 participantsStarted 2018-01-27

Plain-language summary

Create a personalized time and context curve of patient circulating α1-antitrypsin (AAT) levels and functions before hematopoietic stem cell transplantation and throughout progression into GVHD. PRIMARY ENDPOINT 1. Serum AAT levels and activity, before myeloablative preconditioning, as well as on days (-3),0,7,14,28 from HSCT and every 21 days thereafter. SECONDARY ENDPOINTS 1. Correlation between AAT patterns and: * Circulating immune cell activation profiles on day of ablation, 28 days from HSCT and once GVHD is diagnosed. * Patient survival * Liver function tests * GVHD grade: skin manifestations, weight, GI and liver histopathology * Graft-versus-leukemia effect

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Candidates for allogeneic transplantation for the first time, scheduled to receive HSCT from HLA-matched sibling or an unrelated matched donor * Signed informed consent by the donor(Healthy volunteers) and the patient Exclusion Criteria: * Patients undergoing immunosuppressive treatment prior to preparation for bone-marrow transplantation. * Pregnant and disabled patients.

What they're measuring

Number of patients progressing into acute or chronic GVHD

Timeframe: Up to 1 year

Trial details

NCT IDNCT03188601

SponsorRambam Health Care Campus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-01

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