Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
Condition: Lymphoid Leukemia; Myeloid Leukemia; Monocytic Leukemia; Myelodysplasia
MeSH terms: Leukemia; Preleukemia; Leukemia, Lymphoid; Myelodysplastic Syndromes
Intervention: Intravenous (IV) and oral Vitamin C
Intervention description: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours
• After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Vitamin C; Hematopoietic cell transplant (HCT); Non-relapse mortality; Graft versus Host Disease (GVHD)

Summary:

      This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after
      myeloablative allogeneic stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

        A patient must meet all of the following inclusion criteria to be eligible to participate
        in the study:

          1. Any of the following hematological malignancies:

               -  Acute lymphoblastic leukemia

               -  Acute myelogenous leukemia

               -  Chronic myelogenous leukemia

               -  Myelodysplasia

          2. Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without
             previous myeloablative autologous transplant are eligible.

          3. 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)

          4. Stem cell graft from either bone marrow or peripheral blood

          5. Negative serology for HIV

          6. Age ≥ 18 to < 78 years of age

          7. Karnofsky Performance Status of 70-100%

          8. 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

          9. 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.

               1. Known allergy to vitamin C

               2. Inability to swallow oral medication

               3. Known or suspected malabsorption condition or obstruction

               4. G6PDH deficiency

               5. Uncontrolled viral, fungal, or bacterial infection

               6. Active meningeal or central nervous system disease

               7. Alternative hematopoietic cell transplant (HCT) including haplo-identical and
                  umbilical cord transplants

               8. Non-myeloablative conditioning defined as total body irradiation (TBI) < 2
                  centigray (cGy)

               9. Pregnancy or breastfeeding

              10. 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