A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment

Phase 3 Active not recruiting 327 enrolled Geron Corporation

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibitor treatment.

Timeline

Start: 2021-04-12
Primary completion: 2028-06-30
Completion: 2028-06-30

Publications

Mascarenhas J, Harrison CN, Kiladjian JJ, Komrokji RS, Koschmieder S, Vannucchi AM, Berry T, Redding D, Sherman L, Dougherty S, Peng L, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Verstovsek S. Imetelstat in intermediate-2 or high-risk myelofibrosis refractory to JAK inhibitor: IMpactMF phase III study design. Future Oncol. 2022 Jul;18(22):2393-2402. doi: 10.2217/fon-2022-0235. Epub 2022 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imetelstat	Oligonucleotide (other)	9.4 mg/kg	Intravenous
Comparator	Danazol	Other / unclassified	—	—
Comparator	Hydroxyurea	Other / unclassified	—	—
Comparator	Thalidomide	Other / unclassified	—	—

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment

Summary

Timeline

Publications

Drugs

Indications