Non Hodgkin Lymphoma Clinical Trial
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
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.
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
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.
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
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
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There is 1 Location for this study
Richmond Virginia, 23298, United States
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