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

Myelodysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613727
• Other study ID #: MCC-17-13299
• Secondary ID: NCI-2018-01502
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: October 6, 2022

Study information

• Verified date: November 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoid Leukemia
• Monocytic Leukemia
• Myelodysplasia
• Myelodysplastic Syndromes
• Myeloid Leukemia
• Preleukemia

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/ Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
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)	The number of participants who have adverse events related to Vitamin C therapy	Within first 30 days of myeloablative allogeneic HCT