]>
IRCT20140818018842N27 IRCT 2022-12-03 Tehran University of Medical Sciences A study to evaluate the effect of Atorvastatin in GvHD A study to evaluate the efficacy of Atorvastatin in the prophylaxis of acute graft-versus-host disease in allogeneic hematopoietic stem cell transplantation (HSCT) 2015-08-23 anticipated 75 Complete https://irct.ir/trial/16971 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: According to a computer-generated block randomization list, patients are given a code, and then they are divided into groups A (Atorvastatin recipients) and B (placebo recipients). In this study, participants, caregivers, and researchers are blinded to group assignments. The results are reported by the person not involved in the study after completion of the study, Blinding description: According to a computer-generated block randomization list, patients are given a code, and then they are divided into groups A (Atorvastatin recipients) and B (placebo recipients). In this study, participants, caregivers, and researchers are blinded to group assignments. The results are reported by the person not involved in the study after completion of the study. 3 Condition 1: Acute lymphoblastic leukemia [ALL]. Condition 2: Acute myeloid leukemia [AML]. Intervention 1: Intervention group: In this group, Atorvastatin 40 mg (Abidi Pharmaceutical Co.) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 days after transplantation (for transplant recipient) or until the incidence of side effects or severe GVHD. Intervention 2: Control group: In this group, Placebo 40 mg (Abidi Pharmaceutical Co. ) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 days after transplantation (for transplant recipient) or until the incidence of side effects or severe GVHD. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Parsa Rostami
Kargar-e-shomali Ave., Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 rostami.parsa@yahoo.com Tehran University of Medical Sciences scientific Mohammad Vaezi
Kargar-e-Shomali Ave., Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 vaezi.mohammad@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Donor age : 18 years or above Normal liver function in donors Normal renal function in recipients KPS =>60 for donors Patients with a history of hematologic malignancies or bone marrow failure syndromes Recipient age: 18 to 60 years A fully HLA‐matched family donor LVEF=>40% for recipients Normal liver function in recipients Normal renal function in donors KPS =>70 for recipients There is no no prohibition for patients who already received Atorvastatin 18 years 60 years Both Pregnant women and lactating mothers Positive history of hypersensitivity to Atorvastatin in donors HIV-positive donors HIV-positive recipients Positive history of hypersensitivity to Atorvastatin in recipients Patients receiving ATG c91.0 C92.0 Acute myeloblastic leukemia Treatment - Drugs Placebo Intervention group: In this group, Atorvastatin 40 mg (Abidi Pharmaceutical Co.) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 days after transplantation (for transplant recipient) or until the incidence of side effects or severe GVHD. Control group: In this group, Placebo 40 mg (Abidi Pharmaceutical Co. ) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 days after transplantation (for transplant recipient) or until the incidence of side effects or severe GVHD. Acute GVHD. Timepoint: Weekly monitoring until 100 days after transplant. Method of measurement: Clinical assessment. Oral mucositis. Timepoint: Weekly monitoring until 100 days after transplant. Method of measurement: Clinical assessment. Overall survival. Timepoint: Three years after transplantation. Method of measurement: Patient follow-up. Disease-free survival. Timepoint: Three years after transplantation (1- 2 month intervals). Method of measurement: Clinical assessment. Atorvastatin safety. Timepoint: Since 14 days before transplantation until 100 days after transplatation with 15-,30-,60- ,and 90-day intervals. Method of measurement: Clinical assessment as well as monitoring liver and muscle enzymes if necessary. Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences. Approved 2015-05-26 Ethics Committee of Tehran University of Medical Sciences Ethics Committee of Tehran University of Medical Sciences, Keshavararz Blvd. ,Tehran Tehran Tehran Iran (Islamic Republic of)