Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-22 @ 11:14 PM
Study NCT ID:
NCT06345495
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Status:
RECRUITING
Status Verified Date:
2025-09
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:
To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.
Detailed Description:
Primary Objective
1\) Compare the proportion of patients alive, disease free, engrafted, and without poor graft function at 100 days post-transplant with the historical rate of 45%.
Secondary Objectives:
1. Overall survival
2. Progression-free survival
3. Graft vs host disease relapse free survival
4. Relapse rate
5. Non-relapse Mortality
6. Time to Neutrophil and platelet engraftment
7. Time to red cell transfusion independence
8. Graft failure
9. Acute and chronic GVHD
10. Grade 3 -5 Toxicity
11. Incidence of poor graft function5
12. Need for growth factors (myeloid or thrombopoietic) at 100 days
13. Spleen response around day -7, -1, 30, and 100 days
14. Need for transfusions at 100 days
15. Time to discontinuation of immunosuppressives
Exploratory Objectives:
1. Immune reconstitution
2. Cytokine profile
1\) Compare the proportion of patients alive, disease free, engrafted, and without poor graft function at 100 days post-transplant with the historical rate of 45%.
Secondary Objectives:
1. Overall survival
2. Progression-free survival
3. Graft vs host disease relapse free survival
4. Relapse rate
5. Non-relapse Mortality
6. Time to Neutrophil and platelet engraftment
7. Time to red cell transfusion independence
8. Graft failure
9. Acute and chronic GVHD
10. Grade 3 -5 Toxicity
11. Incidence of poor graft function5
12. Need for growth factors (myeloid or thrombopoietic) at 100 days
13. Spleen response around day -7, -1, 30, and 100 days
14. Need for transfusions at 100 days
15. Time to discontinuation of immunosuppressives
Exploratory Objectives:
1. Immune reconstitution
2. Cytokine profile
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-2024-02814 | OTHER | NCI-CTRP Clinical Registry | View |