High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
M.D. Anderson Cancer Center
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.
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…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants 18 years to less than or equal to 75 years. 2. Able to provide written consent. 3. Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib) 4. Enlarged spleen by palpation or imaging. For the purpose of this study, splenomegaly is defined as any clinically palpable spleen or spleen larger than 12 cms on imaging. 5. Has a fully matched (8/8:HLA A, B, C, DRB1) related or matched unrelated donor. 6. Adequate renal function, including: a. Serum creatinine \</= 1.5 mg/dL or estimated Glomerular Filtration Rate (eGFR using t…
Interventions
- DrugRuxolitinib
Given by PO
- ProcedureAllogeneic Stem Cell Transplantation
Given by Transplant
- DrugLevetiracetam
Given by PO
- DrugEltrombopag
Given by PO
- DrugBusulfan
Given by IV
- DrugRomiplostim
Given by IV
- DrugFludarabine phosphate
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas