Allogeneic Hematopoietic Stem Cell Transplantation. Stem cells transplant status
Conditions
Interventions
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
Sponsors
Research Institute for Oncology, Hematology and Cell Therapy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShima Heidari
Tehran University of Medical Sciences
Outcome results
None listed