Clinical trial · Interventional
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
NCT03613727CI-TRIAL-00071069completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Leukemia | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Monocytic Leukemia | Acute Monocytic Leukemia | ALIAS | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous (IV) and oral Vitamin C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IV Vitamin C followed by oral Vitamin C
- description
- All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day.
- interventionNames
- Drug: Intravenous (IV) and oral Vitamin C
Primary outcomes (1)
- measure
- The Proportion of Patients That Experience Non-relapse Mortality (NRM)
- timeFrame
- 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)
- description
- To determine the effect of parenteral vitamin C on non-relapse mortality (NRM) at one year following myeloablative allogeneic HCT. Non-relapse mortality is defined as defined as mortality from complications of HCT but not tumor relapse, is usually from graft versus host disease (GVHD), infection, or organ failure.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.