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RECRUITING Phase 2

Study of Canakinumab in Patients With Myelofibrosis

NCT05467800 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Canakinumab

Study Locations (8)

North Carolina

  • Atrium Health Levine Cancer Institute — Charlotte
  • Wake Forest Baptist Health Comprehensive Cancer Center — Winston-Salem

Arizona

  • Mayo Clinic Arizona — Phoenix

California

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles

Florida

  • Moffitt Cancer Center — Tampa

Kansas

  • The University of Kansas Cancer Center-Westwood — Westwood

New York

  • Ruttenberg Treatment Center — New York

Ohio

  • Cleveland Clinic Foundation — Cleveland

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2022-08-02
Est. Completion 2027-07-01
Phase Phase 2

Sponsor

John Mascarenhas

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05467800

The ClinicalTrials.gov registry entry for NCT05467800 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John Mascarenhas, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 1 intervention — of which Canakinumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05467800 reports 8 study locations spanning 7 distinct geographic areas — top geographies include North Carolina, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05467800 about?

NCT05467800 is a clinical study titled "Study of Canakinumab in Patients With Myelofibrosis". 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 f...

What is the current status of trial NCT05467800?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2022-08-02. Estimated completion is 2027-07-01.

What conditions does trial NCT05467800 study?

This clinical trial studies the following conditions: Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, ET-MF, Post-polycythemia Vera Related Myelofibrosis, PV-MF. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05467800?

The interventions under investigation include: Canakinumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05467800?

This trial is sponsored by John Mascarenhas, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05467800 being conducted?

This trial has 8 study locations across Arizona, California, Florida, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial