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NCT06159491 · ClinicalTrials.gov registry record · Phase 1
Pacritinib in CMML
A Phase 1 study of Chronic Myelomonocytic Leukemia, sponsored by Douglas Tremblay.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT06159491: Recruiting Phase 1 study of Chronic Myelomonocytic Leukemia, sponsored by Douglas Tremblay.
NCT06159491 is a Phase 1 study of Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by Douglas Tremblay. The registered enrollment target is 26 participants, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06159491, a Phase 1 study of Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by Douglas Tremblay.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Pacritinib
Study Locations (1)
New York
- The Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06159491 shows while recruiting
NCT06159491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT06159491 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06159491 about?
NCT06159491 is a clinical study titled "Pacritinib in CMML". 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 ...
What is the current status of trial NCT06159491?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2024-09-18. Estimated completion is 2027-07.
What conditions does trial NCT06159491 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT06159491?
The interventions under investigation include: Azacitidine (DRUG), Pacritinib (DRUG).
Who is sponsoring clinical trial NCT06159491?
This trial is sponsored by Douglas Tremblay, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06159491 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06159491's enrollment target sits among peer trials
26 57th of 73 higher than 17 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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