Study of Canakinumab in Patients With Myelofibrosis

Part of paid clinical trials in Los Angeles, California.

Sponsor
John Mascarenhas
Study ID
NCT05467800
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • ET-MF
  • PV-MF
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Related Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    Canakinumab administered as a subcutaneous injection on day 1 of a 21 day cycle for a core study period of 8 cycles.

Study Details

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.

Key Dates

Start date
Aug 2, 2022
Status verified
May 2026
Primary completion
Oct 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab
    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.

Primary Outcome Measure

Number of participant with response based on IWG-MRT criteria [ Time Frame: 24 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
Moffitt Cancer CenterTampaFlorida33612-
The University of Kansas Cancer Center-WestwoodWestwoodKansas66205-
Ruttenberg Treatment CenterNew YorkNew York10029-
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204-
Wake Forest Baptist Health Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CAMoffitt Cancer Center· Tampa, FLThe University of Kansas Cancer Center-Westwood· Westwood, KSRuttenberg Treatment Center· New York, NYAtrium Health Levine Cancer Institute· Charlotte, NCWake Forest Baptist Health Comprehensive Cancer Center· Winston-Salem, NC

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