Clinical Trial 22095

• Overview

  Study Title:

  A Phase 2 study of Canakinumab in patients with Myelofibrosis

  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).

  Objective:

  Primary Objective: To estimate the efficacy of Canakinumab treatment in patients with PMF, post PV-MF, or post ET-MF. The primary objective of this study is to evaluate efficacy of Canakinumab in patients with MF by the end of 8 cycles (24 weeks) based on IWG-MRT critieria.42 A response is considered any one of the following: complete response, partial response, or clinical improvement (inclusive of anemia response, spleen response, or symptom response). Secondary Objectives To assess the safety and tolerability of Canakinumab as measured by the adverse event profile of Common Terminology Criteria for Adverse Events version 5.0 To assess the efficacy of Canakinumab as determined by response assessment using IWG/ELN criteria at the end of Cycle 4 To evaluate clinical improvement with Canakinumab in patients with MF as it pertains to: - Anemia - Splenomegaly - Disease-related symptoms To assess spleen volume reduction by imaging after cycles 4 and 8 as compared to baseline spleen volume. To determine OS in patients treated with Canakinumab To determine PFS in patients treated with Canakinumab

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  Canakinumab ()

• Inclusion Criteria

  Inclusion Criteria:
  • Patients must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements.
  • Patients must be 18 years of age or older at the time of signing the ICF.
  • Patients must have a pathologically confirmed diagnosis of primary myelofibrosis (PMF) as per the World Health Organization (WHO) diagnostic criteria44 or post-essential thrombocythemia (ET) / post-polycythemia vera (PV) MF according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria.45
  • Patients must have at least one of the following: Hemoglobin > A bone marrow biopsy must be performed within the 30-day screening period; however, a bone marrow biopsy obtained within 90 days of screening without intervening treatments and approved by the study chair may suffice.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Life expectancy of at least 6 months.
  • At least two weeks must have elapsed between the last dose of any MF-directed drug treatments (including investigational therapies and excluding hydroxyurea) and study enrollment.
  • Not eligible for ruxolitinib/fedratinib therapy due to a platelet count of > Recovery to grade 1 or less, or baseline of any toxicities due to prior systemic treatments excluding alopecia.
  • Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within 28 days of starting the study drug. Men and women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence, tubal ligation, vasectomy) prior to cycle 1 day 1 and for 130 days after stopping study treatment. Vasectomy must be performed a minimum of 3 months before study start.
  • Must have adequate organ function as
  • Patient must be willing to receive red blood cell and/or platelet transfusions if indicated.

• Exclusion Criteria

  Exclusion Criteria:
  • Prior malignancy active within the previous 1 year or less, 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.
  • Patient must not have any Cardiac abnormalities.
  • 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.
  • Active tuberculosis (Tb) infection or documented, untreated latent Tb infection (all patients should undergo Tb risk evaluation prior to enrollment with Tb screening performed as per local guidelines.)
  • Active, uncontrolled infection at the time of enrollment, except in cases of localized infections that are unlikely to lead to a systemic infection such as onychomycoses or dental caries.
  • Patients with a new fever (T>38.0o C) or respiratory symptoms are required to undergo laboratory screening for COVID-19.
  • Patients who have undergone prior allo-HSCT for treatment of any hematological disorder or prior solid organ transplant.
  • Any serious or uncontrolled psychiatric or medical disorder that, in the opinion of the investigator, may increase the risk associated with the study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Women who are pregnant or breastfeeding.
  • Patients undergoing concurrent treatment with agents targeting tumor necrosis factor alpha (TNFa) or IL-1 within 28 days of study enrollment.
  • Patients who have received a live vaccination within 30 days before study drug administration (patients should not be treated with live-virus vaccine while undergoing therapy and 130 days after Canakinumab discontinuation).
  • Patients with a condition requiring systemic treatment with corticosteroids within 14 days of study drug administration (i.e. prednisone at doses of > 10 mg). Inhaled or topical steroids and adrenal/pituitary replacement doses 10mg or less daily of prednisone or equivalent are permitted.

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