GVHD Clinical Trial
— AATGVHD-MARKOfficial title:
Relative Inactivity of Alpha-1-antitrypsin After Bone Marrow Transplantation as a Dynamic Biomarker for GVHD and Prognosis: a Prospective Cohort Study
Verified date | April 2023 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Completed |
Enrollment | 27 |
Est. completion date | August 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Soroka Medical Center | Beer sheva | South |
Israel | Rambam MC | Haifa | North |
Israel | Hadassah | Jerusalem | Center |
Israel | Tel Aviv Sourasky Medical Center - Ichilov Hospital | Tel Aviv | Center |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Hadassah Medical Organization, Soroka University Medical Center, Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients progressing into acute or chronic GVHD | Evaluation of patient circulating alpha-1-antitrypsin levels and enzymatic functions as a bio-marker for GVHD progression and grading | Up to 1 year | |
Secondary | Correlation between AAT pattern and survivability, response to immunosuppressive treatment. liver functions, immunocyte activities. | 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 |
Up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02942173 -
CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT
|
Phase 2/Phase 3 | |
Terminated |
NCT01940796 -
Phase I Trial of Brentuximab Vedotin for Refractory Chronic Graft-vs.-Host Disease (GVHD)
|
Phase 1 | |
Completed |
NCT02066051 -
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
|
N/A | |
Not yet recruiting |
NCT05544448 -
In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases
|
N/A | |
Completed |
NCT01295710 -
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
|
Phase 3 | |
Not yet recruiting |
NCT06000982 -
Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis
|
Phase 3 | |
Not yet recruiting |
NCT06075225 -
MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib
|
Phase 2 | |
Active, not recruiting |
NCT03680092 -
Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
|
Phase 2 | |
Not yet recruiting |
NCT06083129 -
Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor
|
Phase 3 | |
Not yet recruiting |
NCT05094765 -
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD
|
Early Phase 1 | |
Active, not recruiting |
NCT05415410 -
Proof-of-concept Trial of Apraglutide in GVHD
|
Phase 2 | |
Completed |
NCT02441075 -
70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014
|
N/A | |
Completed |
NCT02588339 -
Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention
|
Phase 2 | |
Not yet recruiting |
NCT06334367 -
Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT
|
Phase 2 | |
Completed |
NCT03846479 -
Itacitinib for Low Risk GVHD
|
Phase 2 | |
Completed |
NCT02891603 -
A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
|
Phase 1/Phase 2 | |
Completed |
NCT02712762 -
Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
|
||
Completed |
NCT03945591 -
High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
Not yet recruiting |
NCT06411184 -
Safety and Efficacy of Treg Cell in the Treatment of GVHD
|
Phase 1/Phase 2 | |
Terminated |
NCT02338232 -
Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
|
N/A |