Vitamin C With Steroids for Gastrointestinal GVHD

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

October 31, 2029

Conditions
Graft-versus-host-disease (GVHD)Gastrointestinal
Interventions
DRUG

Vitamin C (Ascorbic Acid)

"All patients enrolled on this trial will receive steroids at a minimum dose of prednisone 2 mg/kg/day PO (or methylprednisolone 1.6 mg/kg/day IV) divided into 1-2 daily doses as therapy for acute GVHD. For patients that weigh over 100 kg, maximal starting dose of prednisone will be 200 mg (or methylprednisolone-equivalent).~Patients will be treated with intravenous (IV) or oral (PO) vitamin C depending on the severity of symptoms, ability to tolerate PO intake, and location of treatment (inpatient versus outpatient setting): IV dosing:~50 mg/kg/day divided TID (max 4 grams total/day) PO dosing: 500 mg BID or 1000 mg daily (depending on the prescribed formulation)~Vitamin C will be administered through day 56 from start of vitamin C treatment. Patients initially receiving IV administration may be transitioned to PO formulation once tolerating PO intake; per treating physician discretion."

All Listed Sponsors
collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

lead

Baylor College of Medicine

OTHER