A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Clinical Study to Assess Efficacy and Safety of Ropeginterferon alfa-2b (P1101) in Adult Patients with Pre-fibrotic/Early Primary Myelofibrosis or Overt Primary Myelofibrosis

Clinical Trial Details

The purpose of this study is to determine if investigational Ropeginterferon alfa-2b-njft (P1101) is safe and effective at treating participants with pre-fibrotic/early primary myelofibrosis.

Investigational means that Ropeginterferon alfa-2b-njft (P1101) is not approved by the U.S. Food and Drug Administration.

This is a randomized, double-blind, placebo-controlled study. “Randomized” means that the group you will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. “Double-blind” means that neither you nor the study doctor will know which study group you have been placed in (i.e., if you are receiving P1101 or placebo).

In this study, Ropeginterferon alfa-2b-njft (P1101) will be administered subcutaneously (SC) every 2 weeks.

Participation is expected to last about 2.5 years

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with pre-fibrotic/early PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus.
Participants must not have had major organ transplantation.

Detailed eligibility will be reviewed when contacting the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Ghaith Abu-Zeinah, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2505028893

ClinicalTrials.gov:

NCT06468033

Status

Open to Enrollment

Age Group

Adult

Disease

Myeloproliferative Neoplasms

Myelofibrosis