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Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Nov 11, 2026 → Nov 11, 2027
See other at-risk trials from University of Washington

Record History

  1. Primary and study completion pushed from Nov 11, 2026 to Nov 11, 2027 Eligibility criteria shortened, about 33 words · Secondary endpoints: details revised at 4 of 8 entries · Site details revised Show 3 more changesShow less
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: details revised at 4 of 8 entries
    • Site details revised
  2. Re-verified, no change to tracked fieldsv16
  3. Interventions: Decitabine (Drug), Fedratinib (Drug), Pacritinib (Drug), Questionnaire Administration (Other), Ruxolitinib (Drug) to Biospecimen Collection (Procedure), Decitabine (Drug), Fedratinib (Drug), Pacritinib (Drug), Questionnaire Administration (Other)… Study description expanded, about 13 wordsv15 Show 1 more changeShow less
    • Study description expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Sep 17, 2024, no change to tracked fieldsv13-v14
  5. Primary and study completion dates: Nov 11, 2024 to Nov 11, 2026 Site contact updatedv12 Show 1 more changeShow less
    • Site contact updated
Show 10 earlier versionsHide 10 earlier versions
  1. Interventions: Decitabine (Drug), Fedratinib (Drug), Questionnaire Administration (Other), Ruxolitinib (Drug) to Decitabine (Drug), Fedratinib (Drug), Pacritinib (Drug), Questionnaire Administration (Other), Ruxolitinib (Drug) Eligibility criteria expanded, about 52 words · Study description expanded, about 3 words · Study title expanded, about 1 wordv11 Show 3 more changesShow less
    • Eligibility criteria expanded, about 52 words
    • Study description expanded, about 3 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Site contact updated Eligibility criteria shortened, about 4 wordsv10 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv9
  4. Site contact updatedv8
  5. Collaborators shortened, about 4 wordsv7 See this version in full on ClinicalTrials.gov ↗
  6. Re-verified, no change to tracked fieldsv6
  7. Interventions: Decitabine (Drug), Fedratinib (Drug), Ruxolitinib (Drug) to Decitabine (Drug), Fedratinib (Drug), Questionnaire Administration (Other), Ruxolitinib (Drug) Eligibility criteria expanded, about 32 words · Study description expanded, about 1 wordv5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 32 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Eligibility criteria expanded, about 61 wordsv4 See this version in full on ClinicalTrials.gov ↗
  9. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 19, 2020 to Mar 24, 2020 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 19, 2020 to Mar 24, 2020
    • Site details revised
  10. Start date: Mar 19, 2020 to Apr 19, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib 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, fedratinib, and pacritinib 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, fedratinib, or pacritinib may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated/blast phase myeloproliferative neoplasms.
Trial Details
NCT Number NCT04282187
Lead Sponsor University of Washington
Conditions Acute Myeloid Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Not Otherwise Specified, Polycythemia Vera, Primary Myelofibrosis +1 more
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov