Ignite Creation Date:
2024-05-05 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00539695
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2007-10-02
Brief Title:
Low Dose IL-2 Hematopoietic Stem Cell Transplantation IL2 for GVHD
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase II Trial Using Low Dose IL-2 to Induce Regulatory T Cells in Patients After Allogeneic Hematopoietic Stem Cell Transplantation as Graft Versus Host Disease Prophylaxis
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IL2 for GVHD
Brief Summary:
Patients are being asked to participate in this study because treatment for their disease requires a stem cell transplant SCT Stem cells are the source of normal blood cells found in the bone marrow and lead to recovery of blood counts after bone marrow transplantation With stem cell transplants regardless of whether the donor is a full match to the patient or not there is a risk of developing graft-versus-host disease GVHD
GVHD is a serious and sometimes fatal side effect of SCT GVHD occurs when the new donor stem cells graft recognizes that the body tissues of the patient host are different from those of the donor When this happens cells in the graft may attack the host organs How much this happens and how severe the GVHD is depends on many things including how different the donors cells are the strength of the drugs given in preparation for the transplant the quality of transplanted cells and the age of the person receiving the transplant
Typically acute GVHD occurs in the first 100 days following transplant while chronic GVHD occurs after day 100 Acute GVHD most often involves the skin where it can cause anywhere from a mild rash to complete removal of skin liver where it can anywhere from a rise in liver function tests to liver failure and the gut where it can cause anywhere from mild diarrhea to profuse life-threatening diarrhea Most patients who develop GVHD experience a mild to moderate form but some patients develop the severe life-threatening form
Previous studies have shown that patients who receive SCTs can have a lower number of special T cells in their blood called regulatory T cells than people who have not received stem cell transplants When regulatory T cells are low there appears to be an increased rate of severe acute GVHD A drug known as IL-2 Proleukin has been shown to increase the number of regulatory T cells in patients following stem cell transplant and in this study investigators plan to give low dose IL-2 after transplant
This study is called a phase II study because its major purpose is to find out whether using a low-dose of IL-2 will be effective in preventing acute GVHD Other important purposes are to find out if this treatment helps the patients immune system recover regulatory T cells faster after the transplant This study will assess the safety and toxicity of low-dose IL-2 given to patients after transplantation and determine whether this drug is helpful in preventing GVHD
GVHD is a serious and sometimes fatal side effect of SCT GVHD occurs when the new donor stem cells graft recognizes that the body tissues of the patient host are different from those of the donor When this happens cells in the graft may attack the host organs How much this happens and how severe the GVHD is depends on many things including how different the donors cells are the strength of the drugs given in preparation for the transplant the quality of transplanted cells and the age of the person receiving the transplant
Typically acute GVHD occurs in the first 100 days following transplant while chronic GVHD occurs after day 100 Acute GVHD most often involves the skin where it can cause anywhere from a mild rash to complete removal of skin liver where it can anywhere from a rise in liver function tests to liver failure and the gut where it can cause anywhere from mild diarrhea to profuse life-threatening diarrhea Most patients who develop GVHD experience a mild to moderate form but some patients develop the severe life-threatening form
Previous studies have shown that patients who receive SCTs can have a lower number of special T cells in their blood called regulatory T cells than people who have not received stem cell transplants When regulatory T cells are low there appears to be an increased rate of severe acute GVHD A drug known as IL-2 Proleukin has been shown to increase the number of regulatory T cells in patients following stem cell transplant and in this study investigators plan to give low dose IL-2 after transplant
This study is called a phase II study because its major purpose is to find out whether using a low-dose of IL-2 will be effective in preventing acute GVHD Other important purposes are to find out if this treatment helps the patients immune system recover regulatory T cells faster after the transplant This study will assess the safety and toxicity of low-dose IL-2 given to patients after transplantation and determine whether this drug is helpful in preventing GVHD
Detailed Description:
Participation in this protocol will last about 1 year
To participate in this study the patient will need to have undergone a stem cell transplant Before the treatment starts investigators would like to test the patients blood blood for the number of regulatory T cells already present before beginning IL-2
Treatment Plan
Before the conditioning treatment for the transplant 30 to 40 ml 6 to 8 teaspoonfuls of blood will be collected from the patient for regulatory T cell analysis Approximately same amount of blood will also be collected on day 0 the day of the transplant and at the following times after the transplant day 7 the day the IL-2 will most likely start then weekly for another eleven weeks then monthly for 8 months
On approximately day 7 following the transplant if the patient is well and meets the eligibility requirements the IL-2 injections will begin These will be given subcutaneously as a small injection just under the skin three times per week for 6 weeks The injections may also been given through a special catheter called an Insuflon catheter that is placed just under the skin for a week at a time The first dose must be given in the hospital but the remaining doses can be given at home The patient will be taught how to give the injections to him herself
If the patients body has no serious toxicities from the IL-2 and has not developed severe GVHD the patient can continue to get the injections the same way for an additional 6 weeks If at any time the patient develops severe GVHD or serious toxicity related to the IL-2the injections will be stopped If the patients disease returns relapse or he or she does not engraft accept the donor graft the patient will be removed from the study
The patients labs will be followed closely while heshe is receiving the IL-2 injections as well as heart kidney and lung functions however these are all standard tests that the patient will receive after transplant regardless of participation in this study
To participate in this study the patient will need to have undergone a stem cell transplant Before the treatment starts investigators would like to test the patients blood blood for the number of regulatory T cells already present before beginning IL-2
Treatment Plan
Before the conditioning treatment for the transplant 30 to 40 ml 6 to 8 teaspoonfuls of blood will be collected from the patient for regulatory T cell analysis Approximately same amount of blood will also be collected on day 0 the day of the transplant and at the following times after the transplant day 7 the day the IL-2 will most likely start then weekly for another eleven weeks then monthly for 8 months
On approximately day 7 following the transplant if the patient is well and meets the eligibility requirements the IL-2 injections will begin These will be given subcutaneously as a small injection just under the skin three times per week for 6 weeks The injections may also been given through a special catheter called an Insuflon catheter that is placed just under the skin for a week at a time The first dose must be given in the hospital but the remaining doses can be given at home The patient will be taught how to give the injections to him herself
If the patients body has no serious toxicities from the IL-2 and has not developed severe GVHD the patient can continue to get the injections the same way for an additional 6 weeks If at any time the patient develops severe GVHD or serious toxicity related to the IL-2the injections will be stopped If the patients disease returns relapse or he or she does not engraft accept the donor graft the patient will be removed from the study
The patients labs will be followed closely while heshe is receiving the IL-2 injections as well as heart kidney and lung functions however these are all standard tests that the patient will receive after transplant regardless of participation in this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IL-2 for GVHD | OTHER | Baylor College of Medicine | None |