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

Last updated: November 2, 2023
Sponsor: Virginia Commonwealth University
Overall Status: Completed

Phase

2

Condition

Cancer/tumors

Leukemia

Multiple Myeloma

Treatment

Intravenous (IV) and oral Vitamin C

Clinical Study ID

NCT03613727
MCC-17-13299
NCI-2018-01502
  • Ages 18-77
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: A patient must meet all of the following inclusion criteria to be eligible to participatein the study:

  1. Any of the following hematological malignancies:
  • Acute lymphoblastic leukemia
  • Acute myelogenous leukemia
  • Chronic myelogenous leukemia
  • Myelodysplasia
  1. Candidate for hematopoietic cell transplant (HCT) Note: Patients with or withoutprevious myeloablative autologous transplant are eligible.
  2. human leukocyte antigen (HLA) matched stem cell donor, either related (6/6 or 5/6 locimatched) or unrelated (8/8 or 7/8 loci matched)
  3. Stem cell graft from either bone marrow or peripheral blood
  4. Negative serology for HIV
  5. Age ≥ 18 to < 78 years of age
  6. Karnofsky Performance Status of 70-100%
  7. Women who are not postmenopausal or have not undergone hysterectomy must have adocumented negative serum pregnancy test per standard Massey Cancer Center- VirginiaCommonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (BMT) Programguidelines
  8. 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 celltransplant (SCT) preparative treatments.

Exclusion

Exclusion Criteria:

  • A patient who meets any of the following exclusion criteria is ineligible toparticipate 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 andumbilical cord transplants
  8. Non-myeloablative conditioning defined as total body irradiation (TBI) < 2centigray (cGy)
  9. Pregnancy or breastfeeding
  10. Medical, psychological, or social condition that, in the opinion of theinvestigator, may increase the patient's risk or limit the patient's adherencewith study requirements

Study Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: Intravenous (IV) and oral Vitamin C
Phase: 2
Study Start date:
October 01, 2018
Estimated Completion Date:
October 06, 2022

Study 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.

Connect with a study center

  • Virginia Commonwealth University/ Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

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