This phase I trial tests the safety and tolerability of adding ropeginterferon alfa-2b to standard of care ruxolitinib for the treatment of patients with a type of blood cancer called myelofibrosis. Ropeginterferon alfa-2b is a form of interferon. Interferons are a type of signaling protein normally produced by the body as part of the immune response. Interferons interfere with the division of cancer cells and can slow cancer cell growth. Ropeginterferon alfa-2b is a long-acting form of a type of interferon called interferon alfa-2b. In the body, ropeginterferon alfa-2b causes the production of proteins that modulate the immune system and have anticancer effects. It has been approved for the treatment of polycythemia vera, which is a blood disease within the same group as myelofibrosis and often precedes myelofibrosis. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is already approved for the treatment of myelofibrosis. Adding ropeginterferon alfa-2b to standard ruxolitinib may be a safe and feasible treatment option for patients with myelofibrosis.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07521046.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Approved
Contact: Tsewang Tashi
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of ropeginterferon alfa-2b add-on to ruxolitinib in the study population.
SECONDARY OBJECTIVES:
I. To assess the incidence of patients who achieve > 50% reduction in JAK2 V617F mutation burden.
II. To assess the rate of reduction of JAK2, CALR, MPL mutations allelic burden.
III. To assess the rate of 25% spleen volume reduction at 24 weeks of the combination.
IV. To assess the change in the quality of life Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score.
V. To assess the rate of blastic transformation.
VI. To assess the rate of change in myelofibrosis grade.
EXPLORATORY OBJECTIVES (DONE AS PART OF THE CORRELATIVE STUDY):
I. To assess the change in cytokine profile during therapy.
II. To evaluate the change in somatic mutation allele burdens.
III. To evaluate clonality in female subjects by X-chromosome inactivation clonality assays on samples at different timepoints during the study.
OUTLINE:
Patients receive ropeginterferon alfa-2b subcutaneously (SC) once every 2 weeks (Q2W) for up to 104 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue receiving ropeginterferon alfa-2b beyond 104 weeks at the discretion of the principal investigator. Patients also continue receiving ruxolitinib orally (PO) as per standard of care. Patients undergo echocardiography (ECHO) and chest radiography (x-ray) at screening and undergo magnetic resonance imaging (MRI), bone marrow biopsy and aspiration, and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 5 years.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorTsewang Tashi
