Phase II Study of P1101 in Early Myelofibrosis

Who is this study for? Patients with early myelofibrosis
What treatments are being studied? Ropeginterferon Alfa-2B
Status: Completed
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This pilot phase II trial studies P1101 (polyethyleneglycol \[PEG\]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:

‣ Spleen \>= 5 cm below the left costal margin

⁃ MPN-SAF total symptom score (TSS) \> 10 at baseline

⁃ Hemoglobin \< 10 g/dL

• Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia \[CML\], polycythemia vera \[PV\], myelodysplastic syndrome \[MDS\], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase \[LDH\], anemia, palpable splenomegaly)

• For cohort 1: early stage MF (low or intermediate 1 stage as defined by Dynamic International Prognostic Scoring System \[DIPSS\]) without currently available treatment options

• For cohort 2: intermediate-2 or high risk MF patients as defined by DIPSS either not eligible for ruxolitinib or having failed under ruxolitinib

• No prior treatment for myelofibrosis (for cohort 1 only)

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

• Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)

• Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 14 days prior to registration)

• Aspartate transaminase (AST) =\< 2.5 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration)

• Alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration)

• Calculated creatinine clearance must be \>= 50 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)

• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only

• Ability to complete questionnaire(s) by themselves or with assistance

• Provide informed written consent

• Willing to return to enrolling institution for follow-up

• Willing to provide blood samples for correlative research purposes

Locations
United States
Arizona
Mayo Clinic in Arizona
Scottsdale
Time Frame
Start Date: 2015-08-12
Completion Date: 2023-11-30
Participants
Target number of participants: 11
Treatments
Experimental: Treatment (PEG-proline-interferon alpha-2b)
Patients receive PEG-proline-interferon alpha-2b SC on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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