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

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

Detailed Description
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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.

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

Conditions
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Lymphoid Leukemia, Myeloid Leukemia, Monocytic Leukemia, Myelodysplasia

Intervention / Treatment
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* Drug: Intravenous (IV) and oral Vitamin C


Participation Criteria
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Eligibility Criteria
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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 hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible. 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) 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 Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (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 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. 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 hematopoietic cell transplant (HCT) including haplo-identical and umbilical cord transplants Non-myeloablative conditioning defined as total body irradiation (TBI) < 2 centigray (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Vitamin C followed by oral Vitamin C<br>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<br>* 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<br>* Other names: L-ascorbic acid;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)