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New treatment option for Chronic Myelomonocytic Leukemia
Official title Pacritinib in CMML
ClinicalTrials.gov ID: NCT06159491
What this study is testing
What is Pacritinib?
Pacritinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for chronic myelomonocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants must be JAK inhibitor naïve.
- Participants may be hypomethylating agent (HMA) naïve or can be treated with up to one prior cycle.
You likely can't join if
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used...
- Active Graft Versus Host Disease (GVHD), or any GVHD requiring treatment with immunosuppression, with the exception of topical steroids and systemic...
- 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...
- Other invasive malignancies within the last 3 years, except curatively treated non-melanoma skin cancer, localized prostate, cervical cancer, and any...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.