Chronic Graft-versus-host Disease Clinical Trial
Official title:
A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease
Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize the your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought that IL-2 may help control chronic GVHD by stopping the donor's immune system from 'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in combination with steroids to treat cGVHD.
You will give yourself or be given IL-2 daily through an injection under your skin. You should rotate the injection site, if possible. You will do this once every day for 12 weeks. You will then have 4 weeks off of IL-2. During the first 6 weeks of IL-2, you will continue to take steroids without changing the dose your doctor has set for you while you are on IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you take. While you are on study, a member of the study team will examine you to evaluate your cGVHD. These assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs and gastrointestinal system. You will have clinic visits for evaluation of toxicity and clinical benefit approximately every 4 weeks. You will also have immunologic assays approximately every 8 weeks. Immunologic assays will measure the effect of IL-2 on immune cells. You will be on the study for about 16 weeks. You may continue on study treatment for longer if you experience a clinical benefit. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02991846 -
A Prospective Observational Study for Evaluating CGVHD
|
||
| Recruiting |
NCT02291770 -
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
|
Phase 3 | |
| Terminated |
NCT01226420 -
Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
|
Phase 2 | |
| Active, not recruiting |
NCT02759731 -
Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT01862965 -
Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-versus-host Disease With Prednisone and Everolimus
|
Phase 2 | |
| Completed |
NCT02411474 -
Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD
|
N/A | |
| Completed |
NCT02040623 -
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
|
Phase 2 | |
| Active, not recruiting |
NCT01158105 -
Bortezomib for the Treatment of Refractory Chronic Graft-vs-Host Disease(cGVHD)
|
Phase 2 | |
| Terminated |
NCT01903473 -
Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)
|
Phase 2 | |
| Not yet recruiting |
NCT06458127 -
Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease
|
N/A | |
| Recruiting |
NCT05690971 -
Psychosocial Mobile App for Chronic Graft-Versus-Host Disease
|
N/A | |
| Recruiting |
NCT02918188 -
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
|
Phase 2 | |
| Recruiting |
NCT01765660 -
Mesenchymal Stem Cells for Treatment of Refractory Chronic Graft-versus-host Disease
|
Phase 2 | |
| Completed |
NCT01956903 -
Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.
|
Phase 1/Phase 2 | |
| Terminated |
NCT03584516 -
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04692376 -
MSC for Treatment of cGVHD After Allo-HSCT
|
Phase 2 | |
| Completed |
NCT02966301 -
Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide
|
Phase 2 | |
| Terminated |
NCT01898377 -
Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children
|
Phase 2 | |
| Recruiting |
NCT02611180 -
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
|
||
| Recruiting |
NCT02669251 -
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1/Phase 2 |