High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorM.D. Anderson Cancer Center
About this trial
To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.
Eligibility criteria
Qualifiers
Participants 18 years to less than or equal to 75 years.
Able to provide written consent.
Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib)
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.
Disqualifiers
Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
Ejection fraction <40%
Corrected DLCO < 50%
Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
Trial design
Treatments tested in this trial
- Ruxolitinib
- Allogeneic Stem Cell Transplantation
- Levetiracetam
- Eltrombopag
- Busulfan
- Romiplostim
- Fludarabine phosphate
- Cyclophosphamide
- Mesna
- Tacrolimus
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov