Vitamin C in Allogeneic Hematopoietic Stem Cell Transplantatio

Phase 2

Recruiting

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation.
Stem cells transplant status
Z94.84

Registration Number: IRCT20140818018842N31

Lead Sponsor: Research Institute for Oncology, Hematology and Cell Therapy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 260

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures