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Pacritinib and Azacitidine for CMML

This study is testing a combination of two drugs, Pacritinib and Azacitidine, for people with Chronic Myelomonocytic Leukemia (CMML). CMML is a type of blood cancer. You might be able to join if you are 18 or older and have CMML that has been newly diagnosed or previously treated, as long as you haven't received a specific type of drug called a JAK inhibitor before. If you've had another treatment called a hypomethylating agent (HMA), you must have received only one cycle or less. The researchers want to see if this drug combination is safe and if it helps improve your condition. They will measure how well participants respond to the treatment over 24 weeks.

Study design
This is a Phase 1/2 study, meaning it looks at both safety and effectiveness. It plans to enroll 26 participants.
What's involved
You will take Pacritinib twice daily and receive Azacitidine either intravenously (into a vein) or subcutaneously (under the skin) for 7 days in each 28-day cycle. The study will assess your response over 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures clinical benefit and overall response rate at 24 weeks (6 cycles).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06159491

Pacritinib in CMML

Recruiting
PHASE1Ages 18+InterventionalTreatment
Douglas Tremblay
~26 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:PacritinibAzacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity of Pacritinib in combination with Azacitidine
Measured over at the end of one 28-day cycle
+2 more outcomes measured

Conditions

Chronic Myelomonocytic Leukemia

Explore related trials

Chronic Myelomonocytic Leukemia

NCT06159491

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Mount Sinai Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Douglas Tremblay, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine

Who to contact

Gabriela Bello
[email protected]
212-243-0463
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Participants must be ≥18 years of age at time of signing the Informed Consent Form (ICF).
Participants must voluntarily sign an ICF.
Participants must have a pathologically confirmed diagnosis of chronic myelomonocytic leukemia per World Health Organization (WHO) or International Consensus Classification (ICC)
Participants must be JAK inhibitor naïve.
Participants may be hypomethylating agent (HMA) naïve or can be treated with up to one prior cycle.
Participants must have either proliferative CMML (WBC ≥13 x 109/L) or have intermediate-2 or high risk CMML by the clinical/molecular CMML-specific prognostic scoring system (CPSS-Mol).
Participants must have a life expectancy of at least 24 weeks per investigator.
ECOG performance status ≤ 3.
Females of reproductive potential should use effective contraception during treatment with azacitidine and for 6 months after the last dose and males with female partners of reproductive potential should use effective contraception during treatment with azacitidine and for 3 months after the last dose.
Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.
Must have adequate organ function as demonstrated by the following:
Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement, Gilbert's syndrome, or hemolysis.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN.
Creatinine clearance (CrCl) of ≥30 mL/min.
PT or INR \<=1.5x ULN and PTT or aPTT \<=1.5x ULN.
ANC \>= 500 cells/μL.
Ability to adhere to the study visit schedule and all protocol requirements.
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks or within 5 half-lives of the prior investigational agent, whichever is shorter, of the first dose of treatment.
Active Graft Versus Host Disease (GVHD), or any GVHD requiring treatment with immunosuppression, with the exception of topical steroids and systemic steroids at a dose equivalent to prednisone 10mg or less and at a stable or decreasing dose. Any GVHD treatment (including calcineurin inhibitors) must be discontinued at least 28 days prior to Day 1 of study treatment.
Systemic treatment with a strong CYP3A4 inhibitor or a strong CYP450 inducer within 14 days prior to treatment Day 1 (see Appendix 13.7 and 13.8 for a list of CYP3A4 inhibitors and CYP450 inducers, respectively). Shorter washout periods may be permitted with approval of the Study Chair, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1.
Other invasive malignancies within the last 3 years, except curatively treated non-melanoma skin cancer, localized prostate, cervical cancer, and any curatively treated carcinoma in situ.
Presence of active serious infection.
If a patient is identified to have COVID-19 during the screening period, participants may be considered eligible if in the opinion of the investigator there are no COVID-19 sequlae that may place the patient at a higher risk of receiving investigational treatment.
Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the patient from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Known history of uncontrolled human immunodeficiency virus (HIV).
Significant recent bleeding history defined as NCI CTCAE grade ≥2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury).
Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤100 mg per day), anti-vascular endothelial growth factor (anti-VEGF) agents, and daily use of COX-1 inhibiting Non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1.
Any history of CTCAE grade ≥2 cardiac conditions within 6 months prior to treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the Study Chair, if stable and unlikely to affect patient safety.
Heart failure other than NYHA class I (asymptomatic, without limitation).
QT corrected by the Fridericia method (QTcF) prolongation \>480 ms or other factors that increase the risk for QT interval prolongation (e.g., hypokalemia \[defined as serum potassium \<3.0 mEq/L that is persistent and refractory to correction\], or history of long QT interval syndrome).
Known active systemic hepatitis B, or C infection requiring therapy or known cirrhosis.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or pharmaceutical sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant.
Organ transplant recipients other than bone marrow transplant.
Women who are pregnant or lactating.
Patient with known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of pacritinib, including difficulty swallowing, are not eligible.

What this trial measures

  • Dose-limiting toxicity of Pacritinib in combination with Azacitidineat the end of one 28-day cycle

    Phase 1: The recommended phase 2 dose (RP2D) for the combination of pacritinib with azacitidine will be determined based on the dose limiting toxicity (DLT) rate, defined as the proportion of participants in the DLT-evaluable population that experience a DLT within the first 4 weeks (1 cycle) of initiating treatment at the recommended phase 2 dose.

  • Proportion of participants that achieve clinical benefit or better measured using 2015 MDS/MPN IWG Criteria24 weeks (6 cycles, each cycle is 28 days)

    Phase 2: The preliminary efficacy of pacritinib in combination with azacitidine will be defined as the proportion of participants that achieve clinical benefit or better within 24 weeks (6 cycles, each cyce) of initiating treatment. Clinical benefit as defined by 2015 MDS/MPN IWG criteria within erythroid response, platelet response, neutrophil response, spleen response or symptom response.

  • Overall Response Rate (ORR) to measure clinical benefit24 weeks (6 cycles, each cycle is 28 days)

    Clinical benefit will be determined by evaluating overall response rate (ORR) which is defined by complete remission.