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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06345495
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Uday Popat, MD
Phone (713) 563-0812
Email upopat@mdanderson.org
Status Not yet recruiting
Phase Phase 2
Start date September 30, 2024
Completion date January 1, 2029

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