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IRCT20140818018842N31 IRCT 2023-02-27 Research Institute for Oncology, Hematology and Cell Therapy Vitamin C in Allogeneic Hematopoietic Stem Cell Transplantation VitCHSCT Assessment of the Efficacy of High-Dose Intravenous Vitamin C on Severity of Acute Graft Versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation: A Randomized, Triple-Blind, Placebo-Control Trial 2023-02-19 anticipated 260 Complete https://irct.ir/trial/68237 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Since patient safety is the priority of this research, after the number of patients reaches 28, an interim analysis will be performed and a decision will be made regarding the continuation of the study, Randomization description: For randomization, the Balance Blocked Randomization method will be used Stata software. Random allocation will be done using blocks of sizes 6 and 8. The total sample size will be estimated as 260 patients. In this way, random samples will be determined using the ralloc module (Random allocation of treatments in controlled trials) in Stata software, Blinding description: Regarding the preparation of placebo: Injectable form: the treatment group will receive daily vitamin C in 5% dextrose and the control group will receive an equivalent volume of distilled water in 5% dextrose instead of vitamin C. Due to the blinding of the nursing staff, the preparation of the above solutions will be done by the pharmacist, who is not involved in the research but has the randomization list, in the clean room of the pharmacy of Shariati Hospital. Oral form: It is in the form of effervescent tablets of 500 mg, which drug and placebo with a completely similar appearance are prepared by a pharmaceutical company. The randomization sequence is prepared by a statistician who has no connection with the patients. The researchers and participants will be unaware of the study sequence. After confirming the entry of a new patient into the study and registering the patient's code, the coordinator who is stationed at the patient registration site places the patient in the treatment groups based on the specified randomization sequence. 2-3 Allogeneic Hematopoietic Stem Cell Transplantation. Intervention 1: Intervention group: IV vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant; Day +1 and continuing through Day +14 Each dose of 1 g given in 100 mL of 5% dextrose/water over 30 minutes (33 mg/min) every 8 hours.After completion of the IV vitamin C doses, oral vitamin C 500 mg daily beginning on Day +15 and continuing until Day +100. Intervention 2: Control group: Placebo IV Day +1 to +14, followed with oral, one placebo tablet daily beginning on Day +15 and continuing until Day +100. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Shima Heidari
Kargar-e-shomali Ave., Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 sh.heidari70@gmail.com Tehran University of Medical Sciences scientific Bita Shahrami
Kargar Shomali Ave, Shariati Hospital, Tehran, 14117-13135 I.R.Iran
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 bita.shahrami@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Allogeneic hematopoietic stem cells transplantation due to any of the following hematological malignancies: Acute lymphoblastic leukemia (ALL)/ Acute myelogenous leukemia (AML)/ Myelodysplasia (MDS)/ Hodgkin's lymphoma (HL)/ non-Hodgkin's lymphoma (NHL) Patient age ≥ 18 Patients must also receive a full myeloablative conditioning regimen HLA-full-matched stem cell donor, either related or unrelated from peripheral blood stem cell or bone marrow Estimated creatinine clearance ≥60 ml/min Serum total bilirubin ≤ 2 x upper limit of normal value (ULN) and AST and ALT ≤ 2 x ULN Karnofsky Performance Status of 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Ability to understand and the willingness to sign a written informed consent document 18 years no limit Both Known allergy to vitamin C G6PDH deficiency Patients with hemochromatosis History of kidney stones or oxaluria during the last 5 years Uncontrolled viral, fungal, or bacterial infection Allogeneic or autologous hematopoietic stem cells transplantation in the past 12 monthsPregnancy or breastfeeding Left ventricular ejection fraction < 40% Patient participation in another similar research project simultaneously Pregnancy or breastfeeding Z94.84 Stem cells transplant status Treatment - Drugs Placebo Intervention group: IV vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant; Day +1 and continuing through Day +14 Each dose of 1 g given in 100 mL of 5% dextrose/water over 30 minutes (33 mg/min) every 8 hours.After completion of the IV vitamin C doses, oral vitamin C 500 mg daily beginning on Day +15 and continuing until Day +100 Control group: Placebo IV Day +1 to +14, followed with oral, one placebo tablet daily beginning on Day +15 and continuing until Day +100. Cumulative incidence and severity of acute GVHD. Timepoint: 0 - 100 days after HSCT. Method of measurement: Patients will be monitored for acute GVHD at least daily until discharge and then at each outpatient visit until day 100+. The nature and extent of skin involvement will be determined by examination. Staging will be also based on the extent and type of skin involvement. Gastrointestinal GVHD requires 24-hour stool volume for staging. In addition, a history will be taken to document the presence or absence of abdominal pain, nausea, and vomiting. Patients will also be examined for the presence of ileus. The staging of liver involvement is also determined by the increase in total serum bilirubin. The grade of acute GVHD used to evaluate treatment will be the highest grade developed during the entire evaluation period. Time from transplant to neutrophil engraftment. Timepoint: 0 - 30 Days after HSCT. Method of measurement: Daily CBC or bone marrow aspiration and biopsy if needed. Time from transplant to platelet engraftment. Timepoint: 0 - 30 Days after HSCT. Method of measurement: Daily CBC or bone marrow aspiration and biopsy if needed. Cumulative incidence, severity and duration of oral mucositis. Timepoint: 0 - 100 days after HSCT. Method of measurement: Clinical assessment, oral and pharyngeal mucositis is evaluated clinically and based on CTCAE v5.0 daily until discharge or recovery and then at every outpatient visit to the clinic until day 100+. Safety and tolerability of the vitamin C regimen. Timepoint: 0 - 100 days after HSCT. Method of measurement: Clinical assessment, Vitamin C adverse events (AEs) reported using criteria in the CTCAE v5.0. Ascorbic acid plasma levels in patients receiving MAC regimen. Timepoint: 0 - 30 days after HSCT. Method of measurement: With High-performance liquid chromatography (HPLC) method. Relapse rates. Timepoint: At least 100 days after HSCT. Method of measurement: Bone marrow aspiration and biopsy. Overall survival. Timepoint: At least 100 days after HSCT. Method of measurement: Patient follow-up. Research Institute for Oncology, Hematology and Cell Therapy Approved 2022-09-14 The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences Poursina St., Tehran University of Medical Sciences, Faculty Pharmacy, Institute of Pharmaceutical Sciences (TIPS) Tehran Tehran Iran (Islamic Republic of)