CompletedPhase 2

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

United States61 participantsStarted 2018-10-01

Plain-language summary

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

Age range18 Years – 77 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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

✕. 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)

The Proportion of Patients That Experience Non-relapse Mortality (NRM)

Timeframe: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)

NCT IDNCT03613727

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-06

Results submitted2023-10-06

Who can participate

Age range18 Years – 77 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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

✕. 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)