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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03613727

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma Lymphoid Leukemia Multiple Myeloma Myeloid Leukemia Monocytic Leukemia Non Hodgkin Lymphoma Myelodysplasia	Drug: Intravenous (IV) and oral Vitamin C	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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 Other Names: L-ascorbic acid

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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

Other Names:

L-ascorbic acid

Outcome Measures

Primary Outcome Measures

The proportion of patients that experience non-relapse mortality (NRM) [1 year following myeloablative allogeneic 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.

Secondary Outcome Measures

Time from transplant to engraftment [30 Days after myeloablative allogeneic HCT]
To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.
To determine the effectiveness of reducing GVHD [0 - 180 days after myeloablative allogeneic HCT]
Proportion of patients with a diagnosis of acute GVHD
Characterize the safety and tolerability of the vitamin C regimen [Within first 30 days of myeloablative allogeneic HCT]
Determine adverse events (AEs) reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 HCT Note: Patients with or without previous myeloablative autologous transplant are eligible.
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 MCC-VCUHS 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 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 HCT including haplo-identical and umbilical cord transplants
Non-myeloablative conditioning defined as TBI < 2 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