Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
Hodgkin Lymphoma, Lymphoid Leukemia, Multiple Myeloma
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)
Eligibility Criteria
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 HCT Note: Patients with or without previous myeloablative autologous transplant are eligible.
- 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 MCC-VCUHS 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 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 HCT including haplo-identical and umbilical cord transplants
- Non-myeloablative conditioning defined as TBI < 2 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
Sites / Locations
- Virginia Commonwealth University/ Massey Cancer Center
Arms of the Study
Arm 1
Experimental
IV Vitamin C followed by oral Vitamin C
All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day.