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Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis

ConditionMyelofibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subject aged ≥ 18 years.

Diagnosed with PMF, post-PV MF, or post-ET MF per WHO 2016 or 2022 criteria, bearing one of these MPN phenotype defining mutations (JAK2, CALR, and MPL), and with a DIPSS score of low, intermediate-1 or intermediate-2.

Subjects must be already on standard of care ruxolitinib per the treating physician for at least 3 months or more, and on a stable dose for at least 6 weeks prior to screening.

Subjects must have spleen volume of > 450ml by either MRI or CT scan

Disqualifiers

PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.

Receiving other investigational agents.

Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).

Evidence of severe retinopathy or clinically significant eye disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • ropeginterferon alfa- 2b

    Drug

    Ropeginterferon alfa- 2b will be administered as a subcutaneous injection every two weeks.

  • Ruxolitinib

    Drug

    Ruxolitinib will be administered per standard of care.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Treatment: All PatientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type

To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.

Time frame
2 years
2

The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 6.0).

To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.

Time frame
2 years
3

The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.

To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.

Time frame
2 years
4

The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.

To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.

Time frame
2 years

Secondary outcomes

1

The proportion of subjects who achieve >50% reduction in JAK2 V617F mutation burden.

To assess the incidence of patients who achieve \>50% reduction in JAK2 V617F mutation burden.

Time frame
2 years
2

Change in JAK2, CALR, MPL mutations allelic burden.

To assess the rate of reduction of JAK2, CALR, MPL mutations allelic burden.

Time frame
2 years
3

The proportion of subjects who achieve a 25% decrease in spleen volume by 24 weeks from initiation of combination treatment.

To assess the rate of 25% spleen volume reduction at 24 weeks of the combination (Abdominal MRI will be done for spleen size measurement).

Time frame
24 weeks
4

Change in quality of life Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) from baseline and throughout treatment.

To assess the change in the quality of life MPN-SAF TSS score. The MPN-SAF questionnaire consists of 10 questions asking patients to rate their symptoms on a scale of 1 to 10, with 0 being no symptoms and 10 being the worst symptoms.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

PharmaEssentia

Collaborator

Source ClinicalTrials.gov
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