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