OncoMatch/Clinical Trials/NCT06159491
Pacritinib in CMML
Is NCT06159491 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Pacritinib and Azacitidine for chronic myelomonocytic leukemia.
Treatment: Pacritinib · Azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: JAK inhibitor
Participants must be JAK inhibitor naïve.
Lab requirements
Blood counts
ANC ≥ 500 cells/μL
Kidney function
Creatinine clearance (CrCl) of ≥30 mL/min
Liver function
Serum total bilirubin ≤ 2.0 x ULN unless considered due to leukemic organ involvement, Gilbert's syndrome, or hemolysis; AST and ALT ≤ 3.0 x ULN
Cardiac function
PT or INR ≤1.5x ULN and PTT or aPTT ≤1.5x ULN; QTcF ≤480 ms; no CTCAE grade ≥2 cardiac conditions within 6 months prior to treatment Day 1 (except asymptomatic grade 2 non-dysrhythmia cardiovascular conditions with approval); heart failure other than NYHA class I excluded
Must have adequate organ function as demonstrated by the following: Serum total bilirubin ≤ 2.0 x ULN unless considered due to leukemic organ involvement, Gilbert's syndrome, or hemolysis. AST and 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. QTcF ≤480 ms. Any history of CTCAE grade ≥2 cardiac conditions within 6 months prior to treatment Day 1. Heart failure other than NYHA class I (asymptomatic, without limitation).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Mount Sinai Hospital · New York, New York
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