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Vitamin
Intravenous (IV) and oral Vitamin C for Myelodysplasia
Phase 2
Waitlist Available
Led By William B Clark, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following myeloablative allogeneic hematopoietic cell transplant (hct)
Awards & highlights
Study Summary
This trial looks at the effect of IV vitamin C after a stem cell transplant.
Eligible Conditions
- Myelodysplasia
- Lymphocytic Leukemia
- Myeloid Leukemia
- Monocytic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year following myeloablative allogeneic hematopoietic cell transplant (hct)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following myeloablative allogeneic hematopoietic cell transplant (hct)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Proportion of Patients That Experience Non-relapse Mortality (NRM)
Secondary outcome measures
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)
Time From Transplant to Engraftment
To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)
Side effects data
From 2022 Phase 2 trial • 61 Patients • NCT0361372736%
Mucositis Oral
25%
Cytomegalovirus Infection Reactivation
25%
Diarrhea
20%
Sepsis
16%
Epstein-Barr Virus Infection Reactivation
16%
Hypoglycemia
15%
Small Intestinal Mucositis
13%
Urinary Tract Infection
9%
Hypotension
9%
Nausea
9%
Hypertension
9%
Lung Infection
7%
Hypoxia
7%
Acute Kidney Injury
7%
Anorexia
7%
Hyperglycemia
7%
Headache
7%
Febrile Neutropenia
5%
Viremia
5%
Dyspnea
5%
Skin Infection
4%
Sinusoidal Obstruction Syndrome
4%
Abdominal Pain
4%
Catheter Related Infection
4%
Fracture
4%
Ventricular Tachycardia
4%
Creatinie Increased
4%
Sinusoidal obstruction syndrome
4%
Syncope
2%
Seizure
2%
Depression
2%
fever
2%
Blood Bilirubin Increased
2%
Enterocolitis Infection Reactivation
2%
Sinus Tachycardia
2%
Fatigue
2%
Tumor Lysis Syndrome
2%
Suicidial Ideation
2%
Spinal Cord Compression
2%
Vision Decreased
2%
Fungemia
2%
Herpes Simplex Reactivation
2%
Back Pain
2%
Hypernatremia
2%
Generalized Muscle Weakness
2%
Optic Nerve Disorder
2%
Muscle Weakness Lower Limb
2%
Heart Failure
2%
Hearing Impaired
2%
Appendicitis
2%
Mucositis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
IV Vitamin C Followed by Oral Vitamin C
Trial Design
1Treatment groups
Experimental Treatment
Group I: IV Vitamin C followed by oral Vitamin CExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous (IV) and oral Vitamin C
2018
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,884,935 Total Patients Enrolled
William B Clark, MDPrincipal InvestigatorMassey Cancer Center
Gary L Simmons, DOPrincipal InvestigatorMassey Cancer Center
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