Lymphoid LeukemiaPhase 2NCT03613727
Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
A Phase 2 study testing Intravenous (IV) and oral Vitamin C in people with Lymphoid Leukemia and Myeloid Leukemia, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Lymphoid Leukemia, Myeloid Leukemia, Monocytic Leukemia
- What is being tested?
- Intravenous (IV) and oral Vitamin C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 6 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/ Massey Cancer Center
Richmond, Virginia, 23298
About this study
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
Read the 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.
- Being tested
- Intravenous (IV) and oral Vitamin C
- Keywords
- Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)
- Medical subject headings
- Leukemia, Lymphoid, Leukemia, Myeloid, Leukemia, Monocytic, Acute, Anemia, Refractory, with Excess of Blasts, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) and oral Vitamin CDrug
Also called L-ascorbic acid
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
| Study group | Role | What they receive |
|---|---|---|
| IV Vitamin C followed by oral Vitamin C | Experimental | 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. Receives: Drug: Intravenous (IV) and oral Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)
Secondary outcomes (3)
Time From Transplant to Engraftment
To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.
Measured: 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
Measured: 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
Measured: Within first 30 days of myeloablative allogeneic HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Oct 2018
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoid LeukemiaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William B Clark, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613727
- Sponsor's protocol ID
- MCC-17-13299
- Other IDs
- NCI-2018-01502
- Status last verified
- Nov 2023
- First submitted
- 27 Jul 2018
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT03613727
- Acronym / sponsor ID
- MCC-17-13299
- Keywords
- Vitamin C, Hematopoietic cell transplant (HCT), Non-relapse mortality, Graft versus Host Disease (GVHD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Vitamin C followed by oral Vitamin C | Experimental | Drug: Intravenous (IV) and oral Vitamin CAll 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. |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A patient must meet all of the following inclusion criteria to be eligible to participate in the study:
- Any of the following hematological malignancies:
- 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
Key exclusion criteria (11 listed)
- A patient who meets any of the following exclusion criteria is ineligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous (IV) and oral Vitamin CAlso: L-ascorbic acidIntravenous (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 | Drug | IV Vitamin C followed by oral Vitamin C |
Primary outcome
The Proportion of Patients That Experience Non-relapse Mortality (NRM)
Time frame: 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.
3 secondary outcomes
Time From Transplant to Engraftment
Time frame: 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT)
To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)
Time frame: 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)
Time frame: Within first 30 days of myeloablative allogeneic HCT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Clark, MD principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous (IV) and oral Vitamin C in people with Lymphoid Leukemia and Myeloid Leukemia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients That Experience Non-relapse Mortality (NRM) (time frame: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.