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NCT05467800 · ClinicalTrials.gov registry record · Phase 2
Study of Canakinumab in Patients With Myelofibrosis
A Phase 2 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by John Mascarenhas.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 8
- Study locations
NCT05467800 is a Phase 2 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis that is actively recruiting participants, run by John Mascarenhas. The registered enrollment target is 14 participants, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (88% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT05467800, a Phase 2 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, is actively recruiting participants, sponsored by John Mascarenhas.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 8
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (88% lower). The listed sponsor is John Mascarenhas, which has 11 total studies on file at ClinicalTrials.gov.
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.
NCT05467800 reports 8 study locations spanning 7 distinct geographic areas - top geographies include North Carolina, Arizona, California.
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.
What interventions are being tested in trial NCT05467800?
The interventions under investigation include: Canakinumab (DRUG).
Who is sponsoring clinical trial NCT05467800?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
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