Acute Myeloid LeukemiaPhase 2NCT04282187
Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
A Phase 2 study testing Decitabine, Ruxolitinib and Fedratinib in people with Acute Myeloid Leukemia and Essential Thrombocythemia, run by University of Washington at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome
- What is being tested?
- Decitabine, Ruxolitinib and Fedratinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 11 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
- Serum creatinine clearance >= 50 ml/min calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)
- Total bilirubin =< 3 unless due to Gilbert's disease or hemolysis (total bilirubin > 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)
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- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) unless thought to be due to MPN disease process (AST/ALT > 3 is allowable if thought due to MPN disease) (assessed within 14 days of study day 1)
- For patient receiving fedratinib, thiamine level should be above the laboratory lower limit of normal (>= 70 nmol/L in the University of Washington [UW]/Seattle Cancer Care Alliance [SCCA] lab). If it is low, it may be repleted but should be rechecked and demonstrated to normalize prior to initiation of therapy
- Patient is considered a potential transplant candidate. The attending/treating physician will determine transplant candidacy at the time of consent
- The use of hydroxyurea prior to study registration is allowed. Patients with symptoms/signs of hyperleukocytosis, white blood count (WBC) > 100,000/uL, or with concern for other complications of high tumor burden or leukostasis (e.g. hypoxia, disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2 /dose) anytime prior to enrollment
- Capable of providing valid informed consent
Who cannot join
- 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
- Treatment with any other anti-MDS/leukemia investigational agent within 2 weeks of start of study drugs
- For patients planning to receive fedratinib: concurrent use of strong and moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be discontinued
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- For patients planned to receive ruxolitinib AND platelets < 50,000/mm^2: concurrent use of a strong CYP3A4 inhibitor that cannot be discontinued
- For patients planned to receive pacritinib, corrected QT interval (QTc) > 480 msec (changing of medications/supplementing electrolytes is allowed to determine if this helps QTc reduce to < 480 msec)
- For patients planned to receive pacritinib, concurrent use of medications that are CYP1A2, CYP3A4, P-gp, BCRP, OCT1 substrates that cannot be discontinued
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Noah Pinke, 206-606-4942, ntpinke@fredhutch.org
Anna Halpern
About this study
Official title: A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated/Blast Phase Myeloproliferative Neoplasms
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.
Read the detailed 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), fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and bone marrow samples throughout the trial.
After completion of study treatment, patients are followed up for up to 5 years.
- Conditions
- Acute Myeloid Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Not Otherwise Specified
- Being tested
- Decitabine, Ruxolitinib, Fedratinib, Questionnaire Administration, Pacritinib
- Keywords
- Myeloid and Monocytic Leukemia, Other Hematopoietic
- Medical subject headings
- Leukemia, Myeloid, Acute, Thrombocythemia, Essential, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Myeloproliferative Disorders, Polycythemia Vera, Primary Myelofibrosis, Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called 127716, 2''-Deoxy-5-azacytidine, 5-Aza-2''-deoxycytidine, Dacogen
Given IV
RuxolitinibDrug
Also called 941678-49-5, INCB-18424, Jakafi, Oral JAK Inhibitor INCB18424
Given PO
FedratinibDrug
Also called 936091-26-8, SAR302503, TG101348
Given PO
Questionnaire AdministrationOther
Ancillary studies
PacritinibDrug
Also called 937272-79-2, Oral JAK2 Inhibitor SB1518, SB 1518, SB-1518
Given PO
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of blood and bone marrow samples
| Study group | Role | What they receive |
|---|---|---|
| Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) | Experimental | Patients receive decitabine IV QD over 1 hour on days 1-10, and either ruxolitinib PO BID, fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and bone marrow samples throughout the trial. Receives: Drug: Decitabine; Drug: Ruxolitinib; Drug: Fedratinib; Other: Questionnaire Administration; Drug: Pacritinib; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)
Measured: Up to 5 years
Secondary outcomes (8)
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.
Measured: Up to day 0 of HCT
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.
Measured: At day 100
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.
Measured: From day 0 of HCT, assessed until 12 months post HCT
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.
Measured: From day 0 of HCT, assessed until 12 months post HCT
Mutational profiling
Mutational data will be descriptive. The study team will record mutations found on the next generation of sequencing assays and will watch how these profiles change over time
Measured: Up to 5 years
Response rates regardless of transplant status
Assessed via 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.
Measured: From day 1 of study treatment, assessed up to 5 years
Overall survival regardless of transplant status
Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.
Measured: From day 1 of study treatment, assessed up to 5 years
Relapse-free survival regardless of transplant status
Estimated as a simple proportion and informally compared to rates seen historically among patients treated with multi-agent chemotherapy or no pre-HCT therapy.
Measured: From day 1 of study treatment, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 Mar 2020
- Primary completion11 Nov 2027 (estimated)
- Study completion11 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Halpern, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282187
- Sponsor's protocol ID
- RG1006644
- Other IDs
- NCI-2020-00749, 10419
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated/Blast Phase Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT04282187
- Acronym / sponsor ID
- RG1006644
- Conditions
- Acute Myeloid Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Not Otherwise Specified
- Keywords
- Myeloid and Monocytic Leukemia, Other Hematopoietic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 11 Nov 2027 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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), fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and bone marrow samples throughout the trial.
After completion of study treatment, patients are followed up for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) | Experimental | Drug: Decitabine, Drug: Ruxolitinib, Drug: Fedratinib, Other: Questionnaire Administration, Drug: Pacritinib, Procedure: Biospecimen CollectionPatients receive decitabine IV QD over 1 hour on days 1-10, and either ruxolitinib PO BID, fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and bone marrow samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
- Serum creatinine clearance >= 50 ml/min calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)
Key exclusion criteria (9 listed)
- 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
- Treatment with any other anti-MDS/leukemia investigational agent within 2 weeks of start of study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DecitabineAlso: 127716, 2''-Deoxy-5-azacytidine, 5-Aza-2''-deoxycytidine, DacogenGiven IV | Drug | Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) |
| RuxolitinibAlso: 941678-49-5, INCB-18424, Jakafi, Oral JAK Inhibitor INCB18424Given PO | Drug | Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) |
| FedratinibAlso: 936091-26-8, SAR302503, TG101348Given PO | Drug | Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) |
| PacritinibAlso: 937272-79-2, Oral JAK2 Inhibitor SB1518, SB 1518, SB-1518Given PO | Drug | Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) |
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo collection of blood and bone marrow samples | Procedure or surgery | Treatment (decitabine, ruxolitinib, fedratinib, pacritinib) |
Primary outcome
Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)
Time frame: Up to 5 years
8 secondary outcomes
Time from diagnosis of myeloproliferative neoplasm (MPN)-accelerated phase (AP)/blast phase (BP) to day 0 of HCT
Time frame: Up to day 0 of HCT
Remission rate
Time frame: At day 100
Overall survival
Time frame: From day 0 of HCT, assessed until 12 months post HCT
Relapse-free survival
Time frame: From day 0 of HCT, assessed until 12 months post HCT
Mutational profiling
Time frame: Up to 5 years
Response rates regardless of transplant status
Time frame: From day 1 of study treatment, assessed up to 5 years
Overall survival regardless of transplant status
Time frame: From day 1 of study treatment, assessed up to 5 years
Relapse-free survival regardless of transplant status
Time frame: From day 1 of study treatment, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Halpern principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine, Ruxolitinib and Fedratinib in people with Acute Myeloid Leukemia and Essential Thrombocythemia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah Pinke (206-606-4942, ntpinke@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.