Clinical Trials Logo

Clinical Trial Summary

The goal of this retrospective observational study is to investigate any possible association among tacrolimus (TAC) blood concentrations, clinical efficacy and tolerability. Therefore, the main questions it aims to answer are: 1. to clarify which variables, how and to what extent influence daily TAC blood concentrations in pediatric allo-hematopoietic stem cell transplantation (HSCT) recipients; 2. to investigate the incidence of graft-versus-host disease (GVHD) and graft failure according to TAC exposure. Pediatric patients administered TAC to prevent GVHD after an allogeneic bone marrow transplantation.


Clinical Trial Description

Patients undergoing allo-HSCT will be recruited at IRCC Burlo Garofolo, collecting demographic and clinical characteristics from electronic medical records in a retrospective manner: age, sex, primary disease, donor type and stem cell source, body weight (BW), white blood cell (WBC) count, platelet count, red blood cell (RBC) counts, hemoglobin (HGB) and hematocrit (HCT) levels, red cell concentrate (RCC) transfusions. Other clinical laboratory data (i.e., liver and kidney function) will be included, as well as concomitant drugs administered to patients after allo-HSCT (i.e, mycophenolate mofetil, steroids, pantoprazole, voriconazole, methotrexate). Data will be collected, validated, and presented according to Good Clinical Practice (GCP) principles to support the statistical analyses and subsequent reporting. Once selected according to predefined inclusion requirements, data will be collected anonymously; an identification code will be assigned to each case. As per GCP, all collected information will be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification with user access restriction, and data will be retrievable by designated personnel only. Because of the retrospective nature of the present research protocol, all eligible patients will be included in the study population only if their medical and laboratory records will be complete. Statistical analyses (for descriptive and comparative aims) will be performed stratifying patients by body weight, age, gender, and source of stem cells. Univariate and multivariate tests will be used, together with Kaplan-Meyer tes, Cox proportional hazard model and ROC curve analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06080490
Study type Observational
Source University of Pisa
Contact Natalia Maximova, MD
Phone 040.3785.111
Email natalia.maximova@burlo.trieste.it
Status Recruiting
Phase
Start date September 29, 2023
Completion date September 29, 2025

See also
  Status Clinical Trial Phase
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Withdrawn NCT04728646 - Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes Phase 4
Suspended NCT01972438 - A Randomized, Controlled, Double-masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients Phase 1/Phase 2
Completed NCT01221766 - Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease N/A
Recruiting NCT01764100 - Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD) Phase 1
Completed NCT00760981 - A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease Phase 1
Terminated NCT00298324 - Myfortic - Treatment for Extensive cGvHD Phase 3
Completed NCT00224874 - Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) Phase 2
Completed NCT00023491 - Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells N/A
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT05111834 - IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms N/A
Completed NCT02841995 - A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease Phase 2
Recruiting NCT06143501 - Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
Recruiting NCT04622956 - GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide Phase 1/Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Not yet recruiting NCT06450925 - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation. N/A
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Recruiting NCT01042509 - Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease N/A
Terminated NCT00117702 - Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and Everolimus Phase 2/Phase 3