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

ConditionsAcute Myeloid LeukemiaEssential ThrombocythemiaMyelodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMyeloproliferative NeoplasmMyeloproliferative Neoplasm, Not Otherwise SpecifiedPolycythemia VeraPrimary MyelofibrosisSecondary Myelofibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

History of MPN as defined by the 2016 World Health Organization criteria, with now pathologically confirmed >= 5% blasts in the bone marrow or peripheral blood. Prior MPNs could include polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, MPN unclassifiable, MDS/MPN overlap

Outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution by pathology. Flow cytometric analysis of peripheral blood and/or bone marrow should be performed according to institutional practice guidelines

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky >= 60%

Disqualifiers

Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN with >= 5% blasts in the blood or marrow. Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy is allowed

Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired [e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)])

Known hypersensitivity to any study drug

Females who are pregnant or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

  • Decitabine

    Drug

    Given IV

  • Ruxolitinib

    Drug

    Given PO

  • Fedratinib

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Pacritinib

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and bone marrow samples

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)

Time frame
Up to 5 years

Secondary outcomes

1

Time from diagnosis of myeloproliferative neoplasm (MPN)-accelerated phase (AP)/blast phase (BP) to day 0 of HCT

Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.

Time frame
Up to day 0 of HCT
2

Remission rate

Assessed via the Mascarenhas criteria. Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.

Time frame
At day 100
3

Overall survival

Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.

Time frame
From day 0 of HCT, assessed until 12 months post HCT
4

Relapse-free survival

Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.

Time frame
From day 0 of HCT, assessed until 12 months post HCT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Source ClinicalTrials.gov
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