Ruxolitinib in Combination With Autotransplant
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|ClinicalTrials.gov Identifier: NCT02469974|
Recruitment Status : Withdrawn (no enrollments)
First Posted : June 12, 2015
Last Update Posted : August 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis MF||Drug: RUXOLITINIB / INC 424 Drug: Filgrastim Drug: Busulfan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ruxolitinib in Combination With High Dose Therapy and Autologous Stem Cell Transplantation for Myelofibrosis|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Ruxolitinib / INC 424
Ruxolitinib, Jakafi ®, will be given orally at standard dose daily for 16 weeks pre ASCT and up to 3 months post-ASCT for 10 patients (allowing for 2 additional screen failures). Patients will restart ruxolitinib at 100 days after the ASCT as long as their platelet count is at least 50 x103. For patients whose platelet count is below 50 x103 at day 100, ruxolitinib should be restarted once platelet count reaches 50 x103. The dose of ruxolitinib can be titrated up as per clinical guidelines. PBSC mobilization will include G-CSF 10 mcg/kg/day. HDC for ASCT will consist of IV busulfan 2.0 mg/KBW once daily x 4 for days -5 to -2.
Drug: RUXOLITINIB / INC 424
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).
Peripheral blood stem cells (PBSC) will be mobilized with filgrastim 10 mcg/kg/day IV
Other Name: Neupogen®
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 -2
Other Name: Busulfex®
- Safety of combining ruxolitinib with autologous HSCT measured by graft failure or death [ Time Frame: 2 years ]Safety of this approach as measured by graft failure or death
- CD34 cells [ Time Frame: 4 years ]Total CD34+ cell dose will be calculated based on results of flow cytometric analysis and patient's weight.
- The regimen related mortality (RRM) [ Time Frame: day 100 ]
- The regimen related mortality (RRM) [ Time Frame: day 365 ]
- Rate of engraftment/graft failure [ Time Frame: 4 years ]
- Time of engraftment for neutrophils and platelets [ Time Frame: 4 years ]
- The incidence of serious infectious complications [ Time Frame: up to 1 year post transplant ]
- Changes in marrow fibrosis score [ Time Frame: at 180 and 365 days post-transplant ]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
- Change in FISH allele [ Time Frame: at 365 days post-transplant ]Changes in FISH abnormalities when present will be measured by cytogenetics.
- Change in JAK allele [ Time Frame: at 365 days post-transplant ]Changes in Jak 2 V617F allele burden when present will be measured by quantitative RT-PCR
- Rate of response [ Time Frame: at 6 months post-transplant ]Overall efficacy will be rated on a scale as complete remission, partial remission, clinical improvement, or stable disease
- Rate of response [ Time Frame: at 1 year post-transplant ]Overall efficacy will be rated on a scale as complete remission, partial remission, clinical improvement, or stable disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469974
|Principal Investigator:||Marina Kremyanskaya, MD, PhD||Icahn School of Medicine at Mount Sinai|