Study of Canakinumab in Patients With Myelofibrosis (NCT05467800)
A Phase 2 Study of Canakinumab in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 122]
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute โ Los Angeles, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (7 Sites)
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute โ Los Angeles, California
- Moffitt Cancer Center โ Tampa, Florida
- The University of Kansas Cancer Center-Westwood โ Westwood, Kansas
- Ruttenberg Treatment Center โ New York, New York
- Atrium Health Levine Cancer Institute โ Charlotte, North Carolina
- Wake Forest Baptist Health Comprehensive Cancer Center โ Winston-Salem, North Carolina
- Cleveland Clinic Foundation โ Cleveland, Ohio
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Primary Myelofibrosis
- CINC424A2X01B Rollover Protocol โ Darlinghurst, New South Wales
- P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk โ Los Angeles, California
- Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis โ Seattle, Washington
- Decitabine in Treating Patients With Myelofibrosis โ Chicago, Illinois
- A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis โ Birmingham, Alabama
Explore by condition: All Primary Myelofibrosis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.