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

NCT03613727 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: MCC-17-13299NCI-2018-01502
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoid Leukemia; Myeloid Leukemia; Monocytic Leukemia; Myelodysplasia

Keywords

Vitamin C; Hematopoietic cell transplant (HCT); Non-relapse mortality; Graft versus Host Disease (GVHD)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)

Secondary Outcomes (3)

• Time From Transplant to Engraftment

  30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT)

• To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)

  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)

  Within first 30 days of myeloablative allogeneic HCT

Study Arms (1)

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.

Drug: Intravenous (IV) and oral Vitamin C

Interventions

Intravenous (IV) and oral Vitamin C 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

Also known as: L-ascorbic acid

IV Vitamin C followed by oral Vitamin C

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any of the following hematological malignancies:
• Acute lymphoblastic leukemia
• Acute myelogenous leukemia
• Chronic myelogenous leukemia
• Myelodysplasia
• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Monocytic, Acute; Anemia, Refractory, with Excess of Blasts; Graft vs Host Disease

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid, Acute; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: BMT- CIT Team
• Organization: Virginia Commonwealth University

masseybmt@vcu.edu

804-628-6430

Study Officials

• William B Clark, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 3, 2018
• Study Start: October 1, 2018
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)