Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who have a stem cell transplant have lower than normal levels of vitamin C in their blood. Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed by oral vitamin C until six months after transplant. The effect of the Vitamin C on non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and to characterize the safety and tolerability of the vitamin C regimen.

Inclusion criteria

A patient must meet all of the following inclusion criteria to be eligible to participate in the study:

• Any of the following hematological malignancies:

• Acute lymphoblastic leukemia
• Acute myelogenous leukemia
• Chronic myelogenous leukemia
• Myelodysplasia
• Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible.
• human leukocyte antigen (HLA) matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)
• Stem cell graft from either bone marrow or peripheral blood
• Negative serology for HIV
• Age ≥ 18 to < 78 years of age
• Karnofsky Performance Status of 70-100%
• Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (BMT) Program guidelines
• Ability to understand and the willingness to sign a written informed consent document. Note: The consent form must be signed and dated prior to initiation of stem cell transplant (SCT) preparative treatments.

Exclusion criteria

• A patient who meets any of the following exclusion criteria is ineligible to participate in the study.

• Known allergy to vitamin C
• Inability to swallow oral medication
• Known or suspected malabsorption condition or obstruction
• G6PDH deficiency
• Uncontrolled viral, fungal, or bacterial infection
• Active meningeal or central nervous system disease
• Alternative hematopoietic cell transplant (HCT) including haplo-identical and umbilical cord transplants
• Non-myeloablative conditioning defined as total body irradiation (TBI) < 2 centigray (cGy)
• Pregnancy or breastfeeding
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements