Decitabine With Ruxolitinib or Fedratinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
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- STATUS
- Recruiting
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- days left to enroll
- 54
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- participants needed
- 25
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- sponsor
- University of Washington
Summary
This phase II trial studies how well decitabine with ruxolitinib or fedratinib works before hematopoietic stem cell transplant in treating patients with accelerated/blast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib and fedratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib or fedratinib, may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated/blast phase myeloproliferative neoplasms.
Description
- OUTLINE
Patients receive decitabine intravenously (IV) once daily (QD) over 1 hour on days 1-10, and either ruxolitinib orally (PO) twice daily (BID) or fedratinib daily on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Details
| Condition | Preleukemia, Acute myeloid leukemia, Acute myeloid leukemia, Myelodysplastic-Myeloproliferative Diseases, Myelosclerosis with myeloid metaplasia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, ESSENTIAL THROMBOCYTHEMIA, Polycythemia Vera, Myeloproliferative Neoplasm, Unclassifiable, Secondary Myelofibrosis |
|---|---|
| Age | 18-100 years |
| Treatment | Decitabine, Ruxolitinib, Fedratinib |
| Clinical Study Identifier | NCT04282187 |
| Sponsor | University of Washington |
| Last Modified on | 19 February 2024 |
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