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

Primary Purpose

Hodgkin Lymphoma, Lymphoid Leukemia, Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous (IV) and oral Vitamin C
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 HCT Note: Patients with or without previous myeloablative autologous transplant are eligible.
  3. 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 MCC-VCUHS 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 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 HCT including haplo-identical and umbilical cord transplants
    8. Non-myeloablative conditioning defined as TBI < 2 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

Sites / Locations

  • Virginia Commonwealth University/ Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV Vitamin C followed by oral Vitamin C

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time from transplant to engraftment
To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.
To determine the effectiveness of reducing GVHD
Proportion of patients with a diagnosis of acute GVHD
Characterize the safety and tolerability of the vitamin C regimen
Determine adverse events (AEs) reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

Full Information

First Posted
July 27, 2018
Last Updated
January 12, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03613727
Brief Title
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
Official Title
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
October 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Lymphoid Leukemia, Multiple Myeloma, Myeloid Leukemia, Monocytic Leukemia, Non Hodgkin Lymphoma, Myelodysplasia
Keywords
Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Vitamin C followed by oral Vitamin C
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Intravenous (IV) and oral Vitamin C
Other Intervention Name(s)
L-ascorbic acid
Intervention Description
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
Primary Outcome Measure Information:
Title
The proportion of patients that experience non-relapse mortality (NRM)
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.
Time Frame
1 year following myeloablative allogeneic HCT
Secondary Outcome Measure Information:
Title
Time from transplant to engraftment
Description
To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.
Time Frame
30 Days after myeloablative allogeneic HCT
Title
To determine the effectiveness of reducing GVHD
Description
Proportion of patients with a diagnosis of acute GVHD
Time Frame
0 - 180 days after myeloablative allogeneic HCT
Title
Characterize the safety and tolerability of the vitamin C regimen
Description
Determine adverse events (AEs) reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time Frame
Within first 30 days of myeloablative allogeneic HCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
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 HCT Note: Patients with or without previous myeloablative autologous transplant are eligible. 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 MCC-VCUHS 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 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 HCT including haplo-identical and umbilical cord transplants Non-myeloablative conditioning defined as TBI < 2 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary L Simmons, DO
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/ Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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