Leukemia, Myelomonocytic, ChronicPhase 2PROSPERANCT07033598
Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
A Phase 2 study testing Pacritinib and Hydroxyurea in people with Leukemia, Myelomonocytic, Chronic, run by Theradex at 6 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn if pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia in adults. The main questions it aims to answer are: Does pacritinib improve disease control compared to hydroxyurea? What medical problems do participants have when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelomonocytic, Chronic
- What is being tested?
- Pacritinib and Hydroxyurea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Jan 2026to Dec 2028
- 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
- Diagnosis of CMML-1 (5th WHO classification), with <10% bone marrow blasts on morphology and <5% peripheral blood blasts.
- Proliferative disease, defined as white blood cell count ≥13 × 10⁹/L.
- Advanced disease, defined as at least one of the following features during screening: spleen palpable ≥5cm below the lower costal margin in the midclavicular line; TSS ≥20; or platelet count <100 × 10⁹/L. For participants in whom spleen palpation is not feasible, an ultrasound exam may be performed for assessment of spleen craniocaudal length (length ≥12 cm by ultrasound is considered splenomegaly).
- ECOG performance status ≤2.
- Adequate organ function: AST and ALT ≤3 × ULN, total bilirubin ≤4 × ULN (≤8 × ULN in participants with Gilbert's syndrome), creatinine clearance >30 mL/min, absolute neutrophil count ≥0.5 × 10⁹/L, PT and PTT ≤1.5 × ULN.
- Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and, along with male participants, must agree to use a highly effective method of contraception from the first dose through 90 days after the last dose.
Who cannot join
- Active malignancy diagnosed within the past 2 years, except for curatively treated non-invasive cancers (e.g., basal/squamous cell skin cancer, low-risk prostate cancer on stable endocrine therapy with PSA stable ≥3 months).
- Allogeneic hematopoietic stem cell transplant within 12 months prior to enrollment, or requiring immunosuppressive therapy within 6 months before enrollment.
- Likely to undergo allogeneic hematopoietic stem cell transplant within 6 months, per investigator assessment.
- Prior systemic treatment with any JAK inhibitor.
- Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
- Participation in another interventional study or use of experimental therapy within 28 days or 5 half-lives, whichever is longer.
Show all 19Show fewer
- Use of hematologic support drugs within 28 days prior to enrollment. Supportive care permitted.
- Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before enrollment, whichever is shorter.
- Use of systemic anticoagulants or antiplatelets (except aspirin ≤100 mg/day) within 14 days prior. Therapeutic anticoagulation allowed if stable for ≥90 days without bleeding events.
- CTCAE Grade ≥2 bleeding within 3 months prior to enrollment, unless due to a reversible cause (e.g., trauma, surgery).
- QTcF >450 ms (men) or >470 ms (women); QTcF up to 480 ms allowed if QRS >100 ms. QTcF may be repeated if affected by reversible factors.
- CTCAE Grade ≥3 cardiac event within 3 months before enrollment.
- Symptomatic heart failure with limitations on ordinary activity.
- Uncontrolled infection at study entry.
- Moderate/severe hepatic impairment (Child-Pugh B or C), or active viral hepatitis:
- HBV: Exclude if HBsAg+ or HBV DNA detectable. HBV antiviral therapy allowed if HBV DNA undetectable.
- HCV: Allowed if HCV Ab+ but RNA negative.
- Uncontrolled HIV or detectable viral load while on antiretrovirals.
- Known hypersensitivity to pacritinib or its excipients (microcrystalline cellulose, polyethylene glycol, magnesium stearate).
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Zach Albaugh contact
Melissa Fischer contact
6 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Winship Cancer Institute at Emory
Atlanta, Georgia, 30322
Suzanne Scott, suzanne.e.scott@emory.edu
Anthony Hunter, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Stephany Hendrickson, SLHendrickson@mdanderson.org
Guillermo Montalban-Bravo, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
Tariq Kewan, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Valentina Pileczki, Valentina.Pileczki@moffitt.org
Zhuoer Xie, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
King's College Hospital, NHS Foundation Trust
London, Greater London, SE5 9RS
Tatenda Chiwewe, tatenda.chiwewe@nhs.net
Austin Kulasekararaj, MBBS, MD
- Recruiting
The Christie, NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Jake Healey, jake.healey@nhs.net
Daniel Wiseman, MD
About this study
Official title: A Randomized Phase 2 Study of Pacritinib vs. Hydroxyurea in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia
The goal of this clinical trial is to learn if pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia in adults. The main questions it aims to answer are:
- Does pacritinib improve disease control compared to hydroxyurea?
- What medical problems do participants have when taking pacritinib or hydroxyurea? Researchers will compare pacritinib to hydroxyurea to see if pacritinib is more effective and better tolerated in people with advanced proliferative chronic myelomonocytic leukemia.
Read more
Participants will be randomly assigned to receive either pacritinib twice a day or hydroxyurea for up to 48 weeks.
After treatment ends, participants will be followed for up to one year.
Read the detailed description
This is a randomized, multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of pacritinib compared to hydroxyurea in adult participants with advanced proliferative chronic myelomonocytic leukemia (CMML). Approximately 66 participants will be randomized in a 2:1 ratio to receive either pacritinib 200 mg twice daily (n=44) or hydroxyurea (n=22) for up to 48 weeks. Randomization will be stratified based on prior therapy (i.e., prior use of hydroxyurea or hypomethylating agents vs. no prior therapy).
The study includes:
- A 28-day screening period
- A 48-week treatment period
- A 30-day post-treatment follow-up
- A survival follow-up phase lasting approximately one year after randomization Participants receiving pacritinib who are not deriving benefit by Week 24, as assessed by the treating physician, will discontinue treatment. Participants in the hydroxyurea arm who are not deriving benefit by Week 24-or who experience non-leukemic disease progression-may switch to pacritinib for the remainder of the treatment period, provided they meet predefined "Safe to Switch" criteria.
Participants who discontinue study therapy due to toxicity, disease progression, or other protocol-defined criteria will enter survival follow-up to monitor overall survival, event-free survival, leukemic-free survival, and receipt of allogeneic hematopoietic stem cell transplant. Data will be collected at least every three months until death, hematopoietic stem cell transplant, or leukemic transformation.
An independent data monitoring committee will oversee safety, with the first review after enrollment of ~18 participants and subsequent reviews approximately every 6 months.
- Conditions
- Leukemia, Myelomonocytic, Chronic
- Being tested
- Pacritinib, Hydroxyurea
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
100-mg capsules
HydroxyureaDrug
capsules or tablets
| Study group | Role | What they receive |
|---|---|---|
| Pacritinib | Experimental | Pacritinib 200 mg twice daily Receives: Drug: Pacritinib |
| Hydroxyurea | Active comparator | Hydroxyurea at doses up to 4 g daily Receives: Drug: Hydroxyurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation.
For participants with baseline hemoglobin <10 g/dL, response is defined as either a ≥1.5 g/dL hemoglobin increase lasting ≥8 weeks without red blood cell transfusion, or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of red blood cell transfusion independence, excluding transfusions given for pretreatment Hb ≤8.5 g/dL.
Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Clinical benefit at Week 24, defined as achieving platelet response in the absence of leukemic transformation.
For participants with baseline platelet counts <100 × 10⁹/L, response is defined as one of the following: an increase to ≥20 × 10⁹/L and by ≥100% for ≥8 weeks without platelet transfusion (if baseline <20 × 10⁹/L); an increase of ≥30 × 10⁹/L for ≥8 weeks without transfusion (if baseline 20-<100 × 10⁹/L); or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of platelet transfusion independence.
Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Clinical benefit at Week 24, defined as achieving neutrophil response in the absence of leukemic transformation.
For participants with baseline ANC ≤1 × 10⁹/L, response is defined as either an increase to >0.5 × 10⁹/L and by ≥100% for ≥8 weeks without myeloid growth factors (if baseline ANC ≤0.5 × 10⁹/L), or an increase by ≥50% for ≥8 weeks without myeloid growth factors (if baseline ANC >0.5 to ≤1 × 10⁹/L).
Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Clinical benefit at Week 24, defined as achieving spleen response in the absence of leukemic transformation.
For participants with baseline spleen ≥5 cm below the left costal margin (midclavicular line), spleen response is defined as a ≥35% reduction in spleen volume at endpoint assessment by MRI or CT.
Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Clinical benefit at Week 24, defined as achieving symptom response in the absence of leukemic transformation.
Among participants with baseline Total Symptom Score (TSS) ≥20 per the MPN-SAF TSS: achieving ≥50% TSS reduction from baseline at the time of endpoint assessment.
Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Secondary outcomes (12)
Clinical benefit at any time, defined as achieving at least one of the primary endpoint clinical benefit response criteria at any time on study.
Measured: Measured from the start of study treatment to the end of treatment, for up to 48 weeks.
Achieving response at Week 24 and 48 according to the IWG 2015 criteria), including the following subtypes: complete response, complete cytogenetic remission, partial remission, marrow response
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Duration of response for primary endpoint (clinical benefit by Week 24)
Measured: Measured from Week 24 through the end of treatment, up to 48 weeks.
Event-free survival
Event-free survival is defined as the time without death from any cause, transformation to AML (including granulocytic sarcoma), or disease progression after ≥3 cycles (Week 12), including CMML-1 to CMML-2 with ≥5% absolute blast increase or worsening splenomegaly.
Measured: Measured from the start of study treatment to the end of treatment, for up to 48 weeks.
Leukemia-free survival, where events include death from any cause or transformation to AML (including granulocytic sarcoma)
Measured: Measured from the start of study treatment to the end of treatment, for up to 48 weeks.
Overall survival
Measured: Measured from the date of initiating study treatment to the date of death from any cause, assessed up to 24 months.
Incidence of allogeneic hematopoietic stem cell transplant.
Measured: Measured from the date of initiating study treatment to the date of allogeneic hematopoietic stem cell transplant., assessed for up to 24 months
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Measured: From the start of the adverse event collection period through 30 days following the last dose of study treatment.
Change in arterial blood pressure measured in mmHg.
Measured: From the start of the study treatment through 30 days following the last dose of study treatment.
Change in pulse rate measured in beats per minute.
Measured: From the start of the study treatment through 30 days following the last dose of study treatment.
Change in respiratory rate measured in breaths per minute.
Measured: From the start of the study treatment through 30 days following the last dose of study treatment.
Change in corrected QT interval measured in milliseconds using 12-lead electrocardiogram.
Measured: From the start of the study treatment through 30 days following the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelomonocytic, ChronicStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be stratified by prior therapy. Within each stratum, participants will be randomly assigned to receive either pacritinib or hydroxyurea in a 2:1 ratio.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theradex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDS/MPN International Working Group (UK Sponsor), Sobi, Inc., H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033598
- Sponsor's protocol ID
- PROSPERA
- Other IDs
- ABNL-MARRO 002
- Acronym
- PROSPERA
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Pacritinib vs. Hydroxyurea in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia
- ClinicalTrials.gov ID
- NCT07033598
- Acronym / sponsor ID
- PROSPERA / PROSPERA
- Conditions
- Leukemia, Myelomonocytic, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- TheradexIndustry (pharma, biotech, devices)
- Collaborators
- MDS/MPN International Working Group (UK Sponsor), Sobi, Inc., H. Lee Moffitt Cancer Center and Research Institute
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
The goal of this clinical trial is to learn if pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia in adults. The main questions it aims to answer are:
- Does pacritinib improve disease control compared to hydroxyurea?
- What medical problems do participants have when taking pacritinib or hydroxyurea? Researchers will compare pacritinib to hydroxyurea to see if pacritinib is more effective and better tolerated in people with advanced proliferative chronic myelomonocytic leukemia.
Participants will be randomly assigned to receive either pacritinib twice a day or hydroxyurea for up to 48 weeks.
After treatment ends, participants will be followed for up to one year.
Detailed description
This is a randomized, multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of pacritinib compared to hydroxyurea in adult participants with advanced proliferative chronic myelomonocytic leukemia (CMML). Approximately 66 participants will be randomized in a 2:1 ratio to receive either pacritinib 200 mg twice daily (n=44) or hydroxyurea (n=22) for up to 48 weeks. Randomization will be stratified based on prior therapy (i.e., prior use of hydroxyurea or hypomethylating agents vs. no prior therapy).
The study includes:
- A 28-day screening period
- A 48-week treatment period
- A 30-day post-treatment follow-up
- A survival follow-up phase lasting approximately one year after randomization Participants receiving pacritinib who are not deriving benefit by Week 24, as assessed by the treating physician, will discontinue treatment. Participants in the hydroxyurea arm who are not deriving benefit by Week 24-or who experience non-leukemic disease progression-may switch to pacritinib for the remainder of the treatment period, provided they meet predefined "Safe to Switch" criteria.
Participants who discontinue study therapy due to toxicity, disease progression, or other protocol-defined criteria will enter survival follow-up to monitor overall survival, event-free survival, leukemic-free survival, and receipt of allogeneic hematopoietic stem cell transplant. Data will be collected at least every three months until death, hematopoietic stem cell transplant, or leukemic transformation.
An independent data monitoring committee will oversee safety, with the first review after enrollment of ~18 participants and subsequent reviews approximately every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be stratified by prior therapy. Within each stratum, participants will be randomly assigned to receive either pacritinib or hydroxyurea in a 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Pacritinib | Experimental | Drug: PacritinibPacritinib 200 mg twice daily |
| Hydroxyurea | Active comparator | Drug: HydroxyureaHydroxyurea at doses up to 4 g daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of CMML-1 (5th WHO classification), with <10% bone marrow blasts on morphology and <5% peripheral blood blasts.
- Proliferative disease, defined as white blood cell count ≥13 × 10⁹/L.
- Advanced disease, defined as at least one of the following features during screening: spleen palpable ≥5cm below the lower costal margin in the midclavicular line; TSS ≥20; or platelet count <100 × 10⁹/L. For participants in whom spleen palpation is not feasible, an ultrasound exam may be performed for assessment of spleen craniocaudal length (length ≥12 cm by ultrasound is considered splenomegaly).
- ECOG performance status ≤2.
- Adequate organ function: AST and ALT ≤3 × ULN, total bilirubin ≤4 × ULN (≤8 × ULN in participants with Gilbert's syndrome), creatinine clearance >30 mL/min, absolute neutrophil count ≥0.5 × 10⁹/L, PT and PTT ≤1.5 × ULN.
Key exclusion criteria (19 listed)
- Active malignancy diagnosed within the past 2 years, except for curatively treated non-invasive cancers (e.g., basal/squamous cell skin cancer, low-risk prostate cancer on stable endocrine therapy with PSA stable ≥3 months).
- Allogeneic hematopoietic stem cell transplant within 12 months prior to enrollment, or requiring immunosuppressive therapy within 6 months before enrollment.
- Likely to undergo allogeneic hematopoietic stem cell transplant within 6 months, per investigator assessment.
- Prior systemic treatment with any JAK inhibitor.
- Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
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 |
|---|---|---|
| Pacritinib100-mg capsules | Drug | Pacritinib |
| Hydroxyureacapsules or tablets | Drug | Hydroxyurea |
Primary outcome
Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation.
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
For participants with baseline hemoglobin <10 g/dL, response is defined as either a ≥1.5 g/dL hemoglobin increase lasting ≥8 weeks without red blood cell transfusion, or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of red blood cell transfusion independence, excluding transfusions given for pretreatment Hb ≤8.5 g/dL. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Clinical benefit at Week 24, defined as achieving platelet response in the absence of leukemic transformation.
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
For participants with baseline platelet counts <100 × 10⁹/L, response is defined as one of the following: an increase to ≥20 × 10⁹/L and by ≥100% for ≥8 weeks without platelet transfusion (if baseline <20 × 10⁹/L); an increase of ≥30 × 10⁹/L for ≥8 weeks without transfusion (if baseline 20-<100 × 10⁹/L); or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of platelet transfusion independence. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Clinical benefit at Week 24, defined as achieving neutrophil response in the absence of leukemic transformation.
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
For participants with baseline ANC ≤1 × 10⁹/L, response is defined as either an increase to >0.5 × 10⁹/L and by ≥100% for ≥8 weeks without myeloid growth factors (if baseline ANC ≤0.5 × 10⁹/L), or an increase by ≥50% for ≥8 weeks without myeloid growth factors (if baseline ANC >0.5 to ≤1 × 10⁹/L). Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Clinical benefit at Week 24, defined as achieving spleen response in the absence of leukemic transformation.
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
For participants with baseline spleen ≥5 cm below the left costal margin (midclavicular line), spleen response is defined as a ≥35% reduction in spleen volume at endpoint assessment by MRI or CT. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
Clinical benefit at Week 24, defined as achieving symptom response in the absence of leukemic transformation.
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
Among participants with baseline Total Symptom Score (TSS) ≥20 per the MPN-SAF TSS: achieving ≥50% TSS reduction from baseline at the time of endpoint assessment. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.
12 secondary outcomes
Clinical benefit at any time, defined as achieving at least one of the primary endpoint clinical benefit response criteria at any time on study.
Time frame: Measured from the start of study treatment to the end of treatment, for up to 48 weeks.
Achieving response at Week 24 and 48 according to the IWG 2015 criteria), including the following subtypes: complete response, complete cytogenetic remission, partial remission, marrow response
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
Duration of response for primary endpoint (clinical benefit by Week 24)
Time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.
Event-free survival
Time frame: Measured from the start of study treatment to the end of treatment, for up to 48 weeks.
Leukemia-free survival, where events include death from any cause or transformation to AML (including granulocytic sarcoma)
Time frame: Measured from the start of study treatment to the end of treatment, for up to 48 weeks.
Overall survival
Time frame: Measured from the date of initiating study treatment to the date of death from any cause, assessed up to 24 months.
Incidence of allogeneic hematopoietic stem cell transplant.
Time frame: Measured from the date of initiating study treatment to the date of allogeneic hematopoietic stem cell transplant., assessed for up to 24 months
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Time frame: From the start of the adverse event collection period through 30 days following the last dose of study treatment.
Change in arterial blood pressure measured in mmHg.
Time frame: From the start of the study treatment through 30 days following the last dose of study treatment.
Change in pulse rate measured in beats per minute.
Time frame: From the start of the study treatment through 30 days following the last dose of study treatment.
Change in respiratory rate measured in breaths per minute.
Time frame: From the start of the study treatment through 30 days following the last dose of study treatment.
Change in corrected QT interval measured in milliseconds using 12-lead electrocardiogram.
Time frame: From the start of the study treatment through 30 days following the last dose of study treatment.
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 18 Aug 2026.
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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.
Zach Albaugh contact
Melissa Fischer contact
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pacritinib and Hydroxyurea in people with Leukemia, Myelomonocytic, Chronic, run by Theradex at 6 sites in 2 countries.
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 6 inclusion and 19 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, United Kingdom. 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 Zach Albaugh (zalbaugh@theradex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation. (time frame: Measured from Week 24 through the end of treatment, up to 48 weeks.). The study lists 5 primary outcomes in all. 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 18 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.