Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06159491

Pacritinib in CMML

Led by Douglas Tremblay · Updated on 2025-08-21

26

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

Sponsors

D

Douglas Tremblay

Lead Sponsor

S

Sobi, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a phase 1/2 trial of pacritinib in combination with azacitidine in patients with Chronic Myelomonocytic Leukemia (CMML). Patients will be newly diagnosed or previously treated but could not have received a prior JAK inhibitor. Patients who have previously been treated with a hypomethylating agent (HMA) must have received ≤ 1 cycle. Pacritinib will be initially tested at a dose of 200mg twice daily (dose level 0) in combination with azacitidine 75mg/m2, which can be administered subcutaneously or intravenously, for 7 days in a 28-day cycle. If there are 2 DLTs in the first 6 patients, there will be a dose escalation to pacritinib 100mg twice daily (dose level -1) and an additional 6 patients will be enrolled. Based on the phase 1, 3+3 dose de-escalation design, 6-12 patients will be enrolled in the phase 1 portion. After the completion of phase 1 and identification of the recommended phase 2 dose (RP2D), the trial will then proceed to phase 2 which will employ a Simon two stage design. This portion will include the 6 patients enrolled during the phase 1 portion at the MTD. An interim analysis for futility will occur. If 3 or fewer patients have had a clinical benefit (CB) or better, as defined by 2015 MDS/MPN IWG criteria, the PI and DSMC will meet to discuss the totality of the evidence and determine if the trial shall proceed. In the second stage, an additional 12 patients will be enrolled.

CONDITIONS

Official Title

Pacritinib in CMML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years or older at the time of signing the consent form.
  • Participants must voluntarily sign an informed consent form.
  • Participants must have a confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to WHO or ICC criteria.
  • Participants must not have been treated previously with a JAK inhibitor.
  • Participants may be treatment-naive or have received up to one prior cycle of hypomethylating agent.
  • Participants must have either proliferative CMML with WBC ≥ 3 x 10^9/L or intermediate-2/high risk CMML by CPSS-Mol scoring.
  • Participants must have a life expectancy of at least 24 weeks.
  • Participants must have an ECOG performance status of 3 or less.
  • Females of reproductive potential must use effective contraception during treatment and for 6 months after last dose; males with female partners of reproductive potential must use contraception during treatment and for 3 months after last dose.
  • Male participants must agree to use contraception from first dose through 90 days after last dose.
  • Participants must have adequate organ function including bilirubin ≤ 2.0 x ULN, AST and ALT ≤ 3.0 x ULN, creatinine clearance ≥ 30 mL/min, coagulation tests ≤ 1.5 x ULN, and ANC ≥ 500 cells/µL.
  • Participants must be able to adhere to the study schedule and requirements.
  • Participants must understand and be willing to sign informed consent.
Not Eligible

You will not qualify if you...

  • Currently participating in or recently completed another investigational study within 2 weeks or 5 half-lives before first dose.
  • Active graft versus host disease requiring immunosuppressive treatment beyond topical steroids or stable low-dose systemic steroids.
  • Use of strong CYP3A4 inhibitors or CYP450 inducers within 14 days prior to treatment.
  • Other invasive cancers within last 3 years except certain treated skin, prostate, cervical cancers, or carcinoma in situ.
  • Presence of active serious infection, including unresolved COVID-19 complications.
  • Serious or unstable medical or psychiatric conditions that increase risk or affect data interpretation.
  • Known uncontrolled HIV infection.
  • Significant bleeding history (grade ≥2) within 3 months unless due to an inciting event.
  • Use of medications increasing bleeding risk within 14 days prior to treatment.
  • History of grade ≥2 cardiac conditions within 6 months prior to treatment, except stable asymptomatic conditions.
  • Heart failure worse than NYHA class I.
  • QTcF prolongation >480 ms or risk factors for QT prolongation.
  • Active systemic hepatitis B or C requiring therapy or known cirrhosis.
  • Immediate family members involved in the study staff unless approved by IRB.
  • Organ transplant recipients other than bone marrow transplant.
  • Pregnant or breastfeeding women.
  • Known gastrointestinal diseases or prior procedures interfering with pacritinib absorption or tolerance, including difficulty swallowing.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

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Research Team

T

Tina Czaplinska

CONTACT

K

Katherine Vandris

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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