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

Phase 2

Completed

• Conditions: Lymphoid Leukemia; Myeloid Leukemia; Monocytic Leukemia; Myelodysplasia
• Interventions: Drug: Intravenous (IV) and oral Vitamin C

• Registration Number: NCT03613727
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-03
• Study Start: 2018-10-01
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Results First Submitted: 2023-10-06
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV Vitamin C followed by oral Vitamin C	Intravenous (IV) and 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.

Primary Outcome Measures

Name	Time	Method
The Proportion of Patients That Experience Non-relapse Mortality (NRM)	1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)	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 Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University/ Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States