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

NCT ID: NCT03613727

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2022-10-06

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.

Conditions

Lymphoid Leukemia; Myeloid Leukemia; Monocytic Leukemia; Myelodysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV Vitamin C followed by oral Vitamin C

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.

Group Type: EXPERIMENTAL

Intravenous (IV) and oral Vitamin C

Intervention Type: DRUG

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

Interventions

Intravenous (IV) and oral Vitamin C

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

Intervention Type: DRUG

Other Intervention Names

L-ascorbic acid

Eligibility Criteria

Inclusion Criteria

1. Any of the following hematological malignancies:

• Acute lymphoblastic leukemia
• Acute myelogenous leukemia
• Chronic myelogenous leukemia
• Myelodysplasia

2. Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible.

3. 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)

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 Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (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 stem cell transplant (SCT) preparative treatments.

Exclusion Criteria

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 hematopoietic cell transplant (HCT) including haplo-identical and umbilical cord transplants

8. Non-myeloablative conditioning defined as total body irradiation (TBI) < 2 centigray (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William B Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2018-01502

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-17-13299

Identifier Type: -

Identifier Source: org_study_id