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Spots Global Cancer Trial Database for Study of Canakinumab in Patients With Myelofibrosis

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Trial Identification

Brief Title: Study of Canakinumab in Patients With Myelofibrosis

Official Title: A Phase 2 Study of Canakinumab in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 122]

Study ID: NCT05467800

Interventions

Canakinumab

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ruttenberg Treatment Center, New York, New York, United States

Contact Details

Name: John Mascarenhas, MD

Affiliation: MOUNT SINAI HOSPITAL

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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