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

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

Study Overview

• Status: Completed
• Conditions: Myeloid Leukemia; Myelodysplasia; Lymphoid Leukemia; Monocytic Leukemia
• Intervention / Treatment: Drug: Intravenous (IV) and oral Vitamin C

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/ Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IV Vitamin C followed by oral Vitamin C; 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.

Drug: Intravenous (IV) and oral Vitamin C; 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; Other Names: L-ascorbic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Patients That Experience Non-relapse Mortality (NRM)	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.	1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Transplant to Engraftment	To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.	30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT)
To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)	Percentage of patients with a diagnosis of acute GVHD	0 - 180 days after myeloablative allogeneic HCT
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)	The number of participants who have adverse events related to Vitamin C therapy	Within first 30 days of myeloablative allogeneic HCT

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: William B Clark, MD, Massey Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin C; Hematopoietic cell transplant (HCT); Non-relapse mortality; Graft versus Host Disease (GVHD)
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Myelodysplastic Syndromes; Leukemia; Preleukemia; Leukemia, Lymphoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: MCC-17-13299; NCI-2018-01502 (Other Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No