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New treatment option for MF
Official title A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
ClinicalTrials.gov ID: NCT07317700
What this study is testing
What is Flonoltinib 75mg?
Flonoltinib 75mg is an investigational medicine, being studied as a potential treatment for mf.
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 trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria.
- Phase 3: a large, late-stage 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 to 80
You may be able to join if
- Age range of 18-80 years old (including threshold), gender not limited;
- Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera...
- Expected survival period greater than 24 weeks;
- ECOG score 0-2 points;
- Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline...
You likely can't join if
- The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from...
- Allergy to experimental drugs and their excipients;
- For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable...
- Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or...
- Individuals with impaired cardiac function (those with ejection fraction\ 450 ms on electrocardiogram (males), QTcF\>470 ms on electrocardiogram...
- Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;
See the full eligibility criteria
- Age range of 18-80 years old (including threshold), gender not limited;
- Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibrosis (PET-MF)...
- Expected survival period greater than 24 weeks;
- ECOG score 0-2 points;
- Splenomegaly: Palpation of the splenic margin reaching or exceeding 5cm below the rib (distance from the intersection of the left clavicle midline and left rib margin to the farthest point of the spleen); Or due to...
- Within 7 days prior to randomization, the main organ functions were generally normal, meeting the following criteria: ALT and AST \ 50 mL/min; INR, PT, and APTT \<= 1.5 × ULN;
- Can understand and voluntarily sign an informed consent form.
- The toxic reactions of previous anti-cancer treatments have not recovered to grade 1 or below (excluding hair loss), or have not fully recovered from previous surgeries;
- Allergy to experimental drugs and their excipients;
- For any significant clinical and laboratory abnormalities, the researchers believe that they affect the safety evaluators, such as: a. uncontrollable diabetes - fasting blood glucose\>250 mg/dL (13.9 mmol/L), b...
- Patients with a history of congestive heart failure (NYHA grade III or above), unstable angina or myocardial infarction, cerebrovascular accidents or thromboembolism within the first 6 months of screening;
- Individuals with impaired cardiac function (those with ejection fraction\ 450 ms on electrocardiogram (males), QTcF\>470 ms on electrocardiogram (females), or those with arrhythmia requiring treatment at the time of...
- Patients with congenital or acquired bleeding disorders or unstable thrombotic diseases requiring anticoagulant therapy;
- Any active infection requiring systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) within the first 14 days of randomization;
- Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: a) HBV infection: patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody...
- Patients who are positive for human immunodeficiency virus antibodies (HIV Ab) or anti Treponema pallidum antibodies (TP Ab) (Treponema pallidum antibodies positive);
- Patients with epilepsy or those taking psychotropic or sedative drugs during screening;
- Pregnant or lactating female patients, female/male patients with fertility who refuse to use contraceptive measures during the trial period and within 6 months after the trial ends;
- Patients who have suffered from other malignant tumors within the past 5 years before the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);
- Patients with combined swallowing difficulties;
- Patients who participated in clinical trials of other new drugs or medical devices within the first month of randomization and took the study drug or used the study device;
- Researchers believe that there are other factors that are not suitable for participating in the experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China. 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.