Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT06598332
Eligibility Criteria:
Inclusion Criteria:
1. Patients 12 years of age or older at time of enrollment.
2. 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.
3. 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.
4. 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.
5. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Exclusion Criteria:
1. Relapsed, progressing or persistent malignancy or evidence of minimal residual disease (MRD) requiring withdrawal of systemic immune suppression.
2. 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.
3. 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
4. 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.
5. Patients on renal replacement therapy.
6. Patients requiring continuous supplemental oxygen (O2 requirement \>2L/min to maintain peripheral O2 saturation \[SpO2\] \>90%).
7. Patients with active hepatic sinusoidal obstructive syndrome (SOS) and/or clinical evidence of impaired hepatic function (ascites or encephalopathy related to liver disease)
8. Abnormal coagulation parameters (PT \> 15 seconds, PTT \> 40 seconds, and/or INR \>1.5)
9. Significant active cardiac disease within the previous 6 months including:
NYHA class 4 CHF Unstable angina Myocardial infarction
10. Known or suspected hypersensitivity to azacytidine.
11. Platelets \<20 and or absolute neutrophil count (ANC) \< 1000.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06598332
Study Brief:
Protocol Section:
NCT06598332