Study of Canakinumab in Patients With Myelofibrosis

Phase 2

Recruiting

• Conditions: Primary Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; PV-MF; ET-MF; Post-polycythemia Vera Related Myelofibrosis
• Interventions: Drug: Canakinumab

• Registration Number: NCT05467800
• Lead Sponsor: John Mascarenhas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Study Start: 2022-08-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-01-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canakinumab	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 Measures

Name	Time	Method
Number of participant with response based on IWG-MRT criteria	24 weeks	Efficacy of Canakinumab as measured by number of participant with response based on the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria. 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 Outcome Measures

Name	Time	Method
Change in Spleen Volume	24 weeks	Change in Spleen Volume as compared to baseline
Progression free survival (PFS)	24 weeks	PFS is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier.
Overall Survival (OS)	24 weeks	OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause).
Number of Adverse Events	24 weeks	The safety and tolerability of Canakinumab as measured by the adverse event profile of Common Terminology Criteria for Adverse Events version 5.0
Response using IWG-MRT	24 weeks	To assess the efficacy of Canakinumab as determined by response assessment using IWG/ELN. Participant's response will be categorized as negative, stable, or positive.
Number of participants with clinical improvement	24 weeks	Clinical improvement (CI) is defined by IWG-MRT criteria. Participants meet CI if meet any of the following: Anemia (Patients will meet IWG-MRT criteria for clinical improvement if their hemoglobin increase by 2g/dl from baseline and/or become transfusion independent.); Splenomegaly (Patients will meet IWG-MRT criteria for clinical improvement if their spleen decreases by ≥30% from baseline volume.); Disease-related symptoms (Patients will meet IWG-MRT criteria for clinical improvement if their MPN-SAF symptom score decreases by ≥50% from baseline)

Trial Locations

Locations (8)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute; 🇺🇸 Los Angeles, California, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

The University of Kansas Cancer Center-Westwood; 🇺🇸 Westwood, Kansas, United States

Ruttenberg Treatment Center; 🇺🇸 New York, New York, United States

Atrium Health Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest Baptist Health Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States