Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598332
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
5-Azacytidine with Steroids for Gastrointestinal GVHD 5-AZA for GVHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Administration of 5-Azacytidine with Steroids for First Line Therapy of Gastrointestinal GVHD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 another donor is graft versus host disease GVHD This happens because of differences between the donated cells graft and the patient bodys cells host The new cells from the donor might see the patients bodys 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 they then have to receive other treatments In addition when GHVD involves the gut it can damage stem cells and can cause long term gut problems such as abdominal pain bowel disturbance In laboratory studies giving a medicine called 5 -azacytidine AZA has been able to protect the gut stem cells and help them recover In this trial the investigators would like to see if AZA can do the same thing when given with steroids in patients with GVHD
Right now doctors and researchers dont know the best treatment for GVHD Acute GVHD is usually treated using high-dose corticosteroids but these dont always work well Even if the GVHD gets better when it involves the gut there can be long term damage to gut stem cells In the laboratory 5 azacytidine AZA 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
AZA has been approved by the US Food and Drug Administration FDA for the treatment of patients with leukemias It has also been used post transplant to try and risk the chance of leukemia coming back and to try and treat GVHD but AZA has not been approved by the FDA for the treatment of acute GVHD
A risk for patients who have received a transplant from another donor is graft versus host disease GVHD This happens because of differences between the donated cells graft and the patient bodys cells host The new cells from the donor might see the patients bodys 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 they then have to receive other treatments In addition when GHVD involves the gut it can damage stem cells and can cause long term gut problems such as abdominal pain bowel disturbance In laboratory studies giving a medicine called 5 -azacytidine AZA has been able to protect the gut stem cells and help them recover In this trial the investigators would like to see if AZA can do the same thing when given with steroids in patients with GVHD
Right now doctors and researchers dont know the best treatment for GVHD Acute GVHD is usually treated using high-dose corticosteroids but these dont always work well Even if the GVHD gets better when it involves the gut there can be long term damage to gut stem cells In the laboratory 5 azacytidine AZA 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
AZA has been approved by the US Food and Drug Administration FDA for the treatment of patients with leukemias It has also been used post transplant to try and risk the chance of leukemia coming back and to try and treat GVHD but AZA has not been approved by the FDA for the treatment of acute GVHD
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 treatment for gut GVHD with steroids
Medical tests before treatment--
Before being treated patient will receive a series of standard medical tests
History and Physical exam
Blood tests to measure blood cells kidney and liver function
A biopsy of the gut to look for GVHD is possible
Serum pregnancy test for female patients who are of child bearing potential
GVHD prophylaxis prevention medication
Corticosteroid treatment
An optional stool research sample
Medical tests during and after treatment--
Patient will receive standard medical tests when getting the GVHD treatment and afterwards
History and Physical exams
Monitoring for GVHD
Blood tests to measure blood cells kidney and liver function
A follow-up biopsy of the gut to look for GVHD is possible
GVHD prophylaxis prevention medication
Corticosteroid treatment
Blood tests to measure blood cells kidney and liver function
Measurements of the tumor by routine imaging studies 6 weeks after the infusion
To learn more about the way that AZA may work on gut stem cells an extra amount of blood will be obtained on the day AZA starts 1 2 4 and 8 weeks after the T-cell infusions and then at 3 6 and 12 months The amount of blood taken will be based on patient weight with up to a maximum of 60 mL 12 teaspoons of blood to be obtained at any one time This volume is considered safe but may be decreased if patient is anemic have a low red blood cell count
If the patient has a repeat gut biopsy to check on their GVHD investigators will request a sample to be used for research purposes
Patients will receive supportive care for any acute or chronic toxicities including blood components or antibiotics and other intervention as appropriate
Medical tests before treatment--
Before being treated patient will receive a series of standard medical tests
History and Physical exam
Blood tests to measure blood cells kidney and liver function
A biopsy of the gut to look for GVHD is possible
Serum pregnancy test for female patients who are of child bearing potential
GVHD prophylaxis prevention medication
Corticosteroid treatment
An optional stool research sample
Medical tests during and after treatment--
Patient will receive standard medical tests when getting the GVHD treatment and afterwards
History and Physical exams
Monitoring for GVHD
Blood tests to measure blood cells kidney and liver function
A follow-up biopsy of the gut to look for GVHD is possible
GVHD prophylaxis prevention medication
Corticosteroid treatment
Blood tests to measure blood cells kidney and liver function
Measurements of the tumor by routine imaging studies 6 weeks after the infusion
To learn more about the way that AZA may work on gut stem cells an extra amount of blood will be obtained on the day AZA starts 1 2 4 and 8 weeks after the T-cell infusions and then at 3 6 and 12 months The amount of blood taken will be based on patient weight with up to a maximum of 60 mL 12 teaspoons of blood to be obtained at any one time This volume is considered safe but may be decreased if patient is anemic have a low red blood cell count
If the patient has a repeat gut biopsy to check on their GVHD investigators will request a sample to be used for research purposes
Patients will receive supportive care for any acute or chronic toxicities including blood components or antibiotics and other intervention as appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None