Status:
WITHDRAWN
5-Azacytidine With Steroids for Gastrointestinal GVHD (5-AZA FOR GVHD)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Graft-Versus-Host Disease(GVHD)
Eligibility:
All Genders
12+ years
Phase:
EARLY_PHASE1
Brief Summary
This study aims to evaluate the safety and feasibility of administering AZA in conjunction with steroids as first line therapy for GI GVHD. A risk for patients who have received a transplant from ano...
Detailed Description
Patients enrolled in this study will receive one cycle of AZA through the vein or as a shot under the skin daily for 5 days. This will start at the same time or within 3 days of starting standard trea...
Eligibility Criteria
Inclusion
- Patients 12 years of age or older at time of enrollment.
- Patients experiencing their initial presentation of stage 1 or greater acute LGI GVHD requiring systemic therapy after allogeneic transplant for any malignant or non-malignant indication using any graft/donor source or conditioning intensity.
- Patients can be enrolled with only a clinically established diagnosis. Biopsy of involved organs with acute GVHD is encouraged but is not required and should not delay study entry.
- Patients should not have received systemic immune suppressive therapy for treatment of active GVHD except for a maximum of 72 hours of steroid therapy prior to enrollment. Topical skin and GI corticosteroids (such as budesonide and oral beclomethasone diproprionate) are allowed.
- Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Exclusion
- 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 acute GVHD after planned donor lymphocyte infusion or planned T cell or NK cell add back are eligible.
- 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
- Patients receiving other drugs for the treatment of GVHD. Note, GVHD prophylaxis agents (e.g., calcineurin inhibitors) may be continued at local Investigator's discretion.
- Patients on renal replacement therapy.
- Patients requiring continuous supplemental oxygen (O2 requirement \>2L/min to maintain peripheral O2 saturation \[SpO2\] \>90%).
- Patients with active hepatic sinusoidal obstructive syndrome (SOS) and/or clinical evidence of impaired hepatic function (ascites or encephalopathy related to liver disease)
- Abnormal coagulation parameters (PT \> 15 seconds, PTT \> 40 seconds, and/or INR \>1.5)
- Significant active cardiac disease within the previous 6 months including:
- NYHA class 4 CHF Unstable angina Myocardial infarction
- Known or suspected hypersensitivity to azacytidine.
- Platelets \<20 and or absolute neutrophil count (ANC) \< 1000.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06598332
Start Date
August 1 2025
End Date
May 1 2029
Last Update
September 22 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030