Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-28 @ 2:15 PM
Study NCT ID:
NCT06973668
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
Status:
RECRUITING
Status Verified Date:
2025-11
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:
The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.
Detailed Description:
Primary Objective:
To compare Grade 2-4 acute graft versus host disease-free survival (GFS) between the MMF and Ruxolitinib arms
Secondary Objectives:
To compare the following between treatment arms:
1. Grade 3-5 adverse event of this regimen as per CTCAE v5.0 criteria.
2. Graft versus host disease-free, relapse-free survival (GRFS)
3. Time to neutrophil and platelet engraftment
4. Incidence of acute and chronic GVHD
5. Relapse incidence
6. Non relapse mortality
7. Overall survival
8. Progression-free survival
9. Chimerism
10. Immunosuppression cessation time
11. Rate of graft failure
Exploratory Objective:
To conduct mechanistic studies to compare immune recovery between arms and correlate these with disease control and GVHD prophylaxis.
To compare Grade 2-4 acute graft versus host disease-free survival (GFS) between the MMF and Ruxolitinib arms
Secondary Objectives:
To compare the following between treatment arms:
1. Grade 3-5 adverse event of this regimen as per CTCAE v5.0 criteria.
2. Graft versus host disease-free, relapse-free survival (GRFS)
3. Time to neutrophil and platelet engraftment
4. Incidence of acute and chronic GVHD
5. Relapse incidence
6. Non relapse mortality
7. Overall survival
8. Progression-free survival
9. Chimerism
10. Immunosuppression cessation time
11. Rate of graft failure
Exploratory Objective:
To conduct mechanistic studies to compare immune recovery between arms and correlate these with disease control and GVHD prophylaxis.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-03239 | OTHER | NCI-CTRP Clinical Trials Registry | View |