Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271616
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-14
Brief Title:
Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Study of Ibrutinib as Prophylaxis for Chronic Graft-Versus-Host Disease GVHD in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation Allo-HCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease GVHD in patients undergoing donor allogeneic hematopoietic cell transplantation HCT An allogeneic hematopoietic cell transplantation allo-HCT is a treatment in which a person receives blood-forming stem cells cells from which all blood cells develop from a genetically similar but not identical donor When healthy stem cells from a donor are infused into a patient they may help the patients bone marrow make more healthy cells and platelets However sometimes the transplanted cells from a donor can attack the bodys normal cells called GVHD Giving ibrutinib after the transplant may stop that from happening Ibrutinib is in a class of medications called kinase inhibitors It works by blocking a protein in the blood called Brutons tyrosine kinase BTK By blocking BTK ibrutinib inhibits certain immune cells that play a role in cGVHD Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the efficacy of ibrutinib in reducing the incidence of National Institutes of Health NIH moderatesevere chronic GVHD by 1-year post-registration Phase II Trial
SECONDARY OBJECTIVES
I To determine the safety of ibrutinib when prescribed as prophylaxis for chronic GVHD
II To determine the cumulative incidence of non-relapse mortality NRM III To determine the cumulative incidence of relapse CIR IV To determine the cumulative incidence of chronic GVHD moderatesevere and all grades
V To determine the cumulative incidence of late acute GVHD LA GVHD VI To determine 1-year overall survival OS from time of transplantation VII To determine NIH moderatesevere chronic GVHD and relapse free survival CRFS
VIII To determine immune suppressive therapy required for therapy of chronic GVHD
IX To determine the cumulative incidence of complete immune suppression IS discontinuation
CORRELATIVE OBJECTIVES
I To describe immune reconstitution post-transplant through serial measure of immune cell subsets and quantitative immunoglobulins
II To determine the efficiency of B-cell receptor BCR signaling blockades using multiparameter time of flight cytometry CyTOF that has been optimized for BTK and IL2-inducible T-cell kinase ITK phosphorylation assessment
III To investigate development of allogeneic antibodies and alloantigen specific B cells in F-M patients before and after ibrutinib
IV To investigate the effects ibrutinib treatment on development of allogeneic B cells
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days 1-30 of each cycle Cycles repeat every 30 days for up to 12 cycles on study Additionally patients undergo an echocardiography prior to registration and blood sample collection throughout study
I To evaluate the efficacy of ibrutinib in reducing the incidence of National Institutes of Health NIH moderatesevere chronic GVHD by 1-year post-registration Phase II Trial
SECONDARY OBJECTIVES
I To determine the safety of ibrutinib when prescribed as prophylaxis for chronic GVHD
II To determine the cumulative incidence of non-relapse mortality NRM III To determine the cumulative incidence of relapse CIR IV To determine the cumulative incidence of chronic GVHD moderatesevere and all grades
V To determine the cumulative incidence of late acute GVHD LA GVHD VI To determine 1-year overall survival OS from time of transplantation VII To determine NIH moderatesevere chronic GVHD and relapse free survival CRFS
VIII To determine immune suppressive therapy required for therapy of chronic GVHD
IX To determine the cumulative incidence of complete immune suppression IS discontinuation
CORRELATIVE OBJECTIVES
I To describe immune reconstitution post-transplant through serial measure of immune cell subsets and quantitative immunoglobulins
II To determine the efficiency of B-cell receptor BCR signaling blockades using multiparameter time of flight cytometry CyTOF that has been optimized for BTK and IL2-inducible T-cell kinase ITK phosphorylation assessment
III To investigate development of allogeneic antibodies and alloantigen specific B cells in F-M patients before and after ibrutinib
IV To investigate the effects ibrutinib treatment on development of allogeneic B cells
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days 1-30 of each cycle Cycles repeat every 30 days for up to 12 cycles on study Additionally patients undergo an echocardiography prior to registration and blood sample collection throughout study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01061 | REGISTRY | None | None |
| 18-008754 | OTHER | Mayo Clinic Institutional Review Board | None |