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Anti-metabolites

5-Azacytidine + Steroids for Graft-versus-Host Disease

Phase < 1
Waitlist Available
Led By Helen Heslop, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients on renal replacement therapy
Significant active cardiac disease within the previous 6 months including NYHA class 4 CHF, Unstable angina, Myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last dose of aza
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of using a medication called AZA along with steroids as the first treatment for gastrointestinal graft versus host disease (GVHD). GVHD is a serious condition where

Who is the study for?
This trial is for individuals aged 12 or older who are experiencing their first episode of acute lower gastrointestinal GVHD after an allogeneic transplant. They must not have had more than 72 hours of steroid treatment for GVHD, except topical steroids. A biopsy is encouraged but not mandatory.
What is being tested?
The study tests the safety and effectiveness of combining a drug called AZA with steroids as the initial treatment for GI GVHD. Researchers want to see if AZA can protect gut stem cells and aid recovery in patients suffering from this condition.
What are the potential side effects?
While specific side effects aren't listed here, AZA may cause blood disorders, nausea, vomiting, and increased risk of infection based on its use in other conditions like leukemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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I have a new case of acute lower GI graft-versus-host disease needing treatment after a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on dialysis.
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I haven't had serious heart problems like heart failure, unstable chest pain, or a heart attack in the last 6 months.
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I have liver problems, including fluid in the abdomen or confusion due to liver disease.
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I need extra oxygen to keep my blood oxygen level above 90%.
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My cancer has returned or is not responding to treatment, and I need to stop immune suppression therapy.
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I do not have any infections, or if I do, they are under control with no signs of getting worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after first dose of aza
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after first dose of aza for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility rate
Treatment-related adverse event (tAE) rate
Secondary study objectives
GVHD response rate
Overall survival (OS)
Progression-free survival (PFS)
+1 more

Side effects data

From 2008 Phase 2 trial • 11 Patients • NCT00382590
33%
Anemia
33%
Death
17%
depression
17%
Infection
17%
chest pain
17%
edema
17%
fatigue
17%
Elevated liver function test
17%
Pneumonia
17%
Congestive Heart Failure
17%
Right periocular hemorrhage
17%
Left ocular hemorrhage
17%
Atrail fibrillation
17%
Thrombocytopenia
17%
Arrythmia
17%
Confusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ara-C
5-Aza + VPA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Patients 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 treatment for gut GVHD with steroids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Azacytidine
2015
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,021 Previous Clinical Trials
6,029,245 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
283 Previous Clinical Trials
81,568 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,823 Total Patients Enrolled
~13 spots leftby Nov 2027
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