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New treatment option for Relapsed Adult AML
Official title Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06613217
What this study is testing
What is zelenirstat?
zelenirstat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed adult aml.
Also referred to as PCLX-001.
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 dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
- Phase 1: an early, usually small safety study
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
- \- The following apply to ALL (dose escalation and dose expansion) patients:
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained before any study-specific...
- Male or female patients aged ≥ 18 years
- A diagnosis of AML as per 2016 WHO classification (Arber et al, 2016)
- Patients must have received at least one prior therapy for AML
You likely can't join if
- \- The following exclusion criteria apply to ALL (dose escalation and dose expansion) patients:
- Acute promyelocytic leukemia.
- Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study
- History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class \> II, unstable angina (angina symptoms at rest)...
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
- Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C
See the full eligibility criteria
Who can join
- \- The following apply to ALL (dose escalation and dose expansion) patients:
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained before any study-specific procedures are performed.
- Male or female patients aged ≥ 18 years
- A diagnosis of AML as per 2016 WHO classification (Arber et al, 2016)
- Patients must have received at least one prior therapy for AML
- Patient must not be eligible for other therapies expected to provide clinical benefit
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Appendix A).
- The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled CNS leukemia at the discretion of the...
- Patients must have adequate liver function as assessed by the following laboratory tests to be conducted within 7 (±3) days before the first dose of study drug:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) unless increase is due to hemolysis or congenital disorder such as Gilbert's syndrome
- ALT and AST ≤ 2.5 times ULN or ≤ 5 times ULN for patients with malignant liver involvement
- Patients must have adequate kidney function, as assessed by both:
- the estimated glomerular filtration rate (eGFR) \>60 mL/min within 7 (±3) days before the first dose of study drug (eGFR to be calculated by the Cockcroft-Gault formula)
- creatinine ≤ 1.5 times the ULN
- Adequate cardiac function per institutional normal measured by echocardiography or multi-gated acquisition (MUGA) scan (Left ventricular ejection fraction (LVEF) ≥ 50%)
- Ability to take oral medication
- Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β- human chorionic gonadotropin (HCG)) pregnancy test obtained within 7 (±3) days before the start of administration of study...
- Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active from signing of the informed consent form for the full study until at least 6 months after the last study...
- Combined (estrogen and progestin containing: oral, intravaginal transdermal and progestin-only (oral, injectable, implantable) hormonal contraception associated with inhibition of ovulation.
- Intra-uterine device (IUD) or intrauterine hormone-releasing system (IUS).
- Bilateral tubal occlusion or vasectomized partner (provided that partner is the sole sexual partner and has received medical assessment of the surgical success).
- Sexual abstinence (reliability to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient).
- Male patients with a female partner of reproductive potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration...
What rules you out
- \- The following exclusion criteria apply to ALL (dose escalation and dose expansion) patients:
- Acute promyelocytic leukemia.
- Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study
- History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class \> II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial...
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
- Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C
- Known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load, CD4+ counts/levels \> 250, no history of...
- Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator's discretion provided that the...
- Infections of CTCAE Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade \> 2
- Uncontrolled seizure disorder requiring therapy with strong CYP3A4 inducers such as carbamazepine and phenytoin
- Previous or concurrent cancer that is distinct in primary site or histology from AML, with the exception of the following previous or concurrent cancer types:
- Curative treatment for localized cancer completed without signs of recurrence and treatment-related toxicity and low risk of recurrence as assessed by the investigator,
- In-situ prostate cancer, Gleason Score \<7, prostate-specific antigen \<10 ng/mL (very low risk and low risk, according to therapy guidelines, e.g., the National Comprehensive Cancer Network guideline; active...
- Inability to swallow oral medications
- Any malabsorption condition that may significantly alter the absorption of PCLX-001.
- Breastfeeding. Female patients must not breastfeed during treatment and until 4 months after last study drug administration.
- Acute toxic effects (CTCAE Grade ≥2) of previous anticancer chemotherapy or immunotherapy that have not yet stabilized or if significant post-treatment toxicities have been observed. (Note however that toxic effects of...
- Patients on active radiation therapy or active antineoplastic therapy for a concurrent malignancy at the time of screen. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is...
- Previous assignment to treatment during this study
- Concomitant participation in another clinical study with investigational medicinal product(s)
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex \> 120 ms (except for bundle branch block pattern), or prolongation of the of the QTc...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.