Pacritinib in CMML
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek minimum 18 lat
- •Potwierdzona diagnoza przewlekłej białaczki mielomonocytowej
- •Nigdy wcześniej nie przyjmował lek z grupy JAK inhibitorów
- •Może być pierwszy raz leczony lub wcześniej przyjmował maksymalnie jeden cykl innego rodzaju chemioterapii
- •Choroba w bardziej zaawansowanym stadium (wysokie liczby białych krwinek lub wysokie ryzyko wg punktacji CPSS-Mol)
- •Oczekiwana przeżywalność co najmniej 6 miesięcy
- •Funkcja nerek, wątroby i krzepnięcia w normie
- •Zdolność do uczęszczania na wizyty i przestrzegania wymogów badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 11, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The Mount Sinai Hospital
New York, United States
Trial contact
Gabriela Bello
Katherine Vandris
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/12/2026.
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