A Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Participants with Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated with Janus Kinase (JAK) Inhibitor


About this study

The purpose of this study is to evaluate the percentage of spleen (largest lymph organ in the body) response and symptom response of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to Janus Kinase (JAK) inhibitor treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of PMF according to the revised WHO criteria; or PET-MF or PPV-MF according to the IWG-MRT criteria
  • DIPSS intermediate-2 or high risk MF
  • Measurable splenomegaly prior to study entry as demonstrated by palpable spleen measuring greater than or equal to (>=) 5 cm below the left costal margin OR spleen volume of >= 450 cm^3 measured by MRI
  • Active symptoms of MF as demonstrated by a symptom score of at least 5 points (on a 0 to10 scale) on at least one of the symptoms or a score of 3 or greater on at least 2 of the symptoms
  • Documented progressive disease during or after JAK inhibitor therapy
  • ECOG performance status 0, 1 or 2

Exclusion Criteria:

  • Peripheral blood blast count of >= 10% or bone marrow blast count of >=10%
  • Prior treatment with imetelstat
  • Major surgery within 4 weeks prior to randomization
  • Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), of any type or known acute or chronic liver disease including cirrhosis
  • Prior history of hematopoietic stem cell transplant

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Naseema Gangat, M.B.B.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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