To determine the safety of the approach of giving RUXOLITINIB before and after an autologous stem cell transplant, as measured by graft failure or death.
Name: RUXOLITINIB / INC 424
Description: Administered orally 5-20 mg twice daily x 16 weeks of therapy prior to attempted peripheral blood stem cells (PBSC) collection, during the collection and rest period and 3 months of therapy after high dose chemotherapy (HDC).Type: DrugRuxolitinib / INC 424
Name: Filgrastim
Description: Peripheral blood stem cells (PBSC) will be mobilized with filgrastim 10 mcg/kg/day IVType: DrugRuxolitinib / INC 424
Name: Busulfan
Description: Conditioning for autologous Hematopoeitic Stem Cell Transplantation (HSCT) will consist of IV busulfan 2.0 mg/KBW once daily x 4 for days -5 to -2Type: DrugRuxolitinib / INC 424
Description: Safety of this approach as measured by graft failure or death
Measure: Safety of combining ruxolitinib with autologous HSCT measured by graft failure or death Time: 2 yearsDescription: Total CD34+ cell dose will be calculated based on results of flow cytometric analysis and patient's weight.
Measure: CD34 cells Time: 4 yearsDescription: The myelofibrosis score will be assessed as per the European Consensus Grading published by Thiele Grading Description at 365 days as compared to 180 days
Measure: Changes in marrow fibrosis score Time: at 180 and 365 days post-transplantDescription: Changes in FISH abnormalities when present will be measured by cytogenetics.
Measure: Change in FISH allele Time: at 365 days post-transplantDescription: Changes in Jak 2 V617F allele burden when present will be measured by quantitative RT-PCR
Measure: Change in JAK allele Time: at 365 days post-transplantDescription: Overall efficacy will be rated on a scale as complete remission, partial remission, clinical improvement, or stable disease
Measure: Rate of response Time: at 6 months post-transplantDescription: Overall efficacy will be rated on a scale as complete remission, partial remission, clinical improvement, or stable disease
Measure: Rate of response Time: at 1 year post-transplantSingle Group Assignment
There is one SNP
Changes in Jak 2 V617F allele burden when present will be measured by quantitative RT-PCR. --- V617F ---