Ruxolitinib in Combination With Autotransplant

Sponsor
Marina Kremyanskaya
Study ID
NCT02469974
Status
Withdrawn

Conditions

  • MF
  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RUXOLITINIB / INC 424 — DRUG
    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).
  • Filgrastim — DRUG
    Peripheral blood stem cells (PBSC) will be mobilized with filgrastim 10 mcg/kg/day IV
  • Busulfan — DRUG
    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

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Aug 2016
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Safety of combining ruxolitinib with autologous HSCT measured by graft failure or death [ Time Frame: 2 years ]

Related Studies