Phase 2
Completed N=55
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
Lymphoid Leukemia · Myeloid Leukemia · Monocytic Leukemia · Myelodysplasia
Source: ClinicalTrials.gov NCT03613727 ↗
Enrolled (actual)
55
Serious AEs
72.7%
Results posted
Nov 2023
Primary outcomePrimary: The Proportion of Patients That Experience Non-relapse Mortality (NRM) — 5 Participants
Summary
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients That Experience Non-relapse Mortality (NRM) |
5 | — |
| SECONDARY Time From Transplant to Engraftment |
12 | — |
| SECONDARY To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD) |
33 | — |
| SECONDARY Determine Related to Vitamin C Therapy Adverse Events (AEs) Reported Using Criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT03613727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.