No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
The University of Hong Kong · Other
Who this trial is looking for
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In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Willing and able to provide informed consent
* Age ≥18 years
* Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria
* Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognosti…
Inclusion Criteria:
* Willing and able to provide informed consent
* Age ≥18 years
* Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria
* Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Platelet count ≥75 x 109/L prior to dosing on Cycle 1 Day 1
* Absolute neutrophil count ≥0.5 x 109/L prior to dosing on Cycle 1 Day 1
* Peripheral blast count ≤10% prior to dosing on Cycle 1 Day 1
* Women of childbearing potential and fertile men must agree to use an approved method of contraception from screening until 30 days after the last dose of ropeginterferon and ruxolitinib.
* Patients with suboptimal response to ruxolitinib as per one of the below:
i. Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as \<10% SVR or \<30% decrease in spleen size from baseline, following an initial response\* ii. Refractory: Ruxolitinib treatment for ≥3 months with \<10% SVR or \<30% decrease in spleen size from baseline.
\* Response to ruxolitinib is defined as a ≥35% reduction in spleen volume from baseline, or a ≥50% reduction in spleen size for baseline spleen sizes \>10 cm below left costal margin (LCM); a non-palpable spleen for baseline spleen sizes between 5-10 cm below LCM; or not eligible for spleen response for baseline spleen \<5 cm below LCM.
Exclusion Criteria:
Subjects will not be eligible for participation if they meet any of the following exclusion criteria:
* Prior or current use of interferon alfa (IFNα) preparations for MPN
* Patients currently on other investigational therapy (ies)
* Contraindications or hypersensitivity to IFNα preparations
* History of organ and haematopoietic stem cell transplantation
* History of splenectomy
* Pregnant or lactating females, or females planning to become pregnant at any time during the study
* Documented autoimmune disease at screening
* Infection with human immunodeficiency virus (HIV)
* Active and uncontrolled infections with hepatitis B virus (HBV) and hepatitis C virus (HCV). Please note that patients on antiviral therapy with undetectable HBV DNA and HCV RNA may be recruited.
* Evidence of severe retinopathy including but not limited to macular degeneration, diabetic retinopathy and hypertensive retinopathy.
* History of clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy.
* Clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy.
* Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)
* Evidence of alcohol or drug abuse within 6 months
* Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local lab parameters:
* Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) \<40 mL/min or serum creatinine \>1.5 x the local upper limit of normal
* Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥2.5 x the local upper limit of normal
* Unwilling or unable to comply with the study protocol
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