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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The proportion of patients that experience non-relapse mortality (NRM)
Secondary Outcome
Time from transplant to engraftment
Condition
Hodgkin Lymphoma
Intervention
Intravenous (IV) and oral Vitamin C
Study Arms / Comparison Groups
IV Vitamin C followed by oral Vitamin C
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
October 1, 2018
Completion Date
October 6, 2022
Primary Completion Date
October 6, 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - 77 Years
Accepts Healthy Volunteers
No
Contacts
Gary L Simmons, DO, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03613727
Organization ID
MCC-17-13299
Secondary IDs
NCI-2018-01502
Responsible Party
Sponsor
Study Sponsor
Virginia Commonwealth University
Study Sponsor
Gary L Simmons, DO, Principal Investigator, Massey Cancer Center
Verification Date
January 2023