Clinical trial NCT03613727: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoid Leukemia
Myeloid Leukemia
Monocytic Leukemia
Myelodysplasia
Keywords: Vitamin C
Hematopoietic cell transplant (HCT)
Non-relapse mortality
Graft versus Host Disease (GVHD)
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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:

* 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 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

Primary outcomes:
measure: The Proportion of Patients That Experience Non-relapse Mortality (NRM)
timeFrame: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)
Secondary outcomes:
measure: Time From Transplant to Engraftment
timeFrame: 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT)
measure: To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)
timeFrame: 0 - 180 days after myeloablative allogeneic HCT
measure: 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)
timeFrame: Within first 30 days of myeloablative allogeneic HCT
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/ Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: William B Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: