A Phase II Study of Ruxolitinib Before, During, and After a Stem Cell Transplant for Myelofibrosis

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Full Title

A Phase II Study of Ruxolitinib Pre-, During- and Post-Hematopoietic Stem Cell Transplantation for Patients With Primary or Secondary Myelofibrosis

Purpose

Ruxolitinib is a drug used to treat myelofibrosis. It works by inhibiting the activity of one of the Janus kinase (JAK inhibitor) family of enzymes, thereby interfering with a signaling pathway called JAK-STAT. In this study, researchers want to see if ruxolitinib is safe and effective when used before, during, and after a stem cell transplant in patients who need this treatment for their disease.

Researchers will determine whether the use of ruxolitinib improves the engraftment rate (how quickly the cells received during the stem cell transplant start to grow and make healthy blood cells). They will also look at the rate of graft-versus-host disease (GVHD), which occurs when immune cells among the transplanted cells attack a patient’s own organs. Ruxolitinib has been shown to lower the rate of GVHD.

Some patients will start ruxolitinib before the transplant, while those who cannot receive this medication before transplantation will receive it before conditioning chemotherapy. Ruxolitinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have myelofibrosis that requires treatment with a stem cell transplant.
  • Patients may not have previously received a stem cell transplant from a donor.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Roni Tamari at 212-639-5987.

Protocol

19-233

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators