Vitamin C With Steroids for Gastrointestinal GVHD
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorBaylor College of Medicine
About this trial
After a transplant from another donor, one risk is graft versus host disease (GVHD) that happens because of differences between the donated cells (graft) and the patient's body cells (host). The new cells from the donor might see the body's cells as different and attack them. GVHD can be very serious and cause death. The standard first treatment for GVHD is corticosteroids but not all patients respond and in cases where they don't, they need to go onto other treatments that may or may not be effective. In addition, when GHVD involves the gut it can damage the cells of the gastrointestinal track causing long term problems such as abdominal pain and bowel disturbance. In laboratory studies giving a vitamin C has been able to protect the gastrointestinal cells and help them recover. In this trial the investigators would like to see if vitamin C can do the same thing when given with steroids in patients with GVHD.
The standard first treatment for acute GVHD is corticosteroids but not all patients respond and in cases where they don't, they need to go onto other treatments that may or may not be effective. In addition, when GHVD involves the gut it can damage the cells of the gastrointestinal track causing long term problems such as abdominal pain and bowel disturbance. In the laboratory vitamin C has been able to protect gut stem cells and help them recover and the investigators would like to learn if this happens in people too.
Vitamin C is a readily available supplement. Vitamin C has NOT been approved by the FDA for the treatment of acute GVHD.
Eligibility criteria
Qualifiers
Patients 5 years of age or older at time of enrollment.
Patients experiencing their initial presentation of stage 2 or greater acute LGI GVHD (with or without other organ involvement) or stage 1 LGI + skin aGVHD requiring systemic therapy after allogeneic transplant for any malignant or non-malignant indication using any graft/donor source or conditioning intensity.
KPS ≥70%
Patients should not have received systemic immune suppressive therapy for treatment of active GVHD except for a maximum of 72 hours of steroid therapy (with or without ruxolitinib) prior to enrollment. Topical skin and GI corticosteroids (such as budesonide and oral beclomethasone diproprionate) are allowed.
Disqualifiers
Relapsed, progressing or persistent malignancy or evidence of minimal residual disease (MRD) requiring withdrawal of systemic immune suppression.
Patients with acute GVHD developing after administration of a donor lymphocyte infusion (DLI) for relapse/progression of disease.
Patients with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms
Known or suspected hypersensitivity to vitamin C.
Trial design
Treatments tested in this trial
- Vitamin C (Ascorbic Acid)
Treatment groups
35 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Baylor College of Medicine
Lead sponsor
The Methodist Hospital Research Institute
Collaborator
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov