Study of Canakinumab in Patients With Myelofibrosis (NCT05467800) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Canakinumab in Patients With Myelofibrosis
United States14 participantsStarted 2022-08-02
Plain-language summary
This is an open label, multicenter, phase 2 trial of Canakinumab in patients with primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF). Eligible patients will receive Canakinumab administered as a subcutaneous injection on day 1 of a 21 day cycle for a core study period of 8 cycles. Canakinumab will be given by subcutaneous injection (SC) injection at a starting dose of 200 mg (one 150 mg/mL syringe and one 50 mg/0.5 mL syringe) every 3 weeks. The interim analysis will be performed when the number of enrolled patients reaches 10. If no responses OR 4 or more patients have unacceptable toxicity, the study will not proceed to the second stage. If the total number of patients reaches the maximum sample size of 26, the treatment is deemed acceptable if the number of responses in the efficacy endpoint are greater than 3, and the number of toxicities are less than 7.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements.
✓. Participants must be ≥ 18 years of age at the time of signing the ICF.
✓. Participants must have a pathologically confirmed diagnosis of PMF as per the World Health Organization (WHO) diagnostic criteria46 or post-ET MF or post-PV MF according to IWG-MRT criteria.47
✓. Participants must have at least one of the following:
✓. Hemoglobin \< 10 g/dL
✓. Transfusion-dependency (at least 6 units of packed red blood cells (PRBC) in the 12 weeks prior to study enrollment, for a hemoglobin \< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia with the most recent transfusion having occurred in the 28 days prior to study enrollment)
✓. Splenomegaly palpated ≥ 5 cm below the left costal margin (LCM) or spleen volume ≥ 450 cc
✓. MFSAF v4.0 TSS ≥ 10
Exclusion criteria
What they're measuring
1
Number of participant with response based on IWG-MRT criteria
. Prior malignancy active within the previous ≤ 1 year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
✕. Any of the following cardiac abnormalities
✕. Uncontrolled, symptomatic congestive heart failure as designated by the treating physician
✕. Myocardial infarction ≤ 6 months prior to enrollment
✕. Unstable angina pectoris designated by treating physician
✕. Serious uncontrolled cardiac arrhythmia as designated by treating physician
✕. Uncontrolled hypertension as designated by treating physician
✕. Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or Hepatitis C.