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

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    320
  • sponsor
    Geron Corporation
Updated on 2 August 2021

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 refractory to Janus Kinase (JAK)-Inhibitor treatment.

Description

This is a multicenter study with 2 arms, and will include 3 phases: a) screening phase of up to 28 days before randomization during which participants will complete a 14-day washout period from all prior therapies including JAK-inhibitor treatment, and the participant's eligibility will be reviewed; b) treatment phase, from randomization until study treatment (imetelstat or BAT) discontinuation; and c) post treatment follow-up phase, that begins when the participant discontinues treatment, and will continue until death, lost to follow-up, withdrawal of consent, or study end, whichever occurs first. Participants will be randomized (2:1) into 2 Arms (Arm A will receive imetelstat and Arm B will receive BAT).

Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval.

Details
Condition Myelosclerosis with myeloid metaplasia, Myelofibrosis
Treatment Imetelstat, Best Available Therapy (BAT)
Clinical Study IdentifierNCT04576156
SponsorGeron Corporation
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of primary myelofibrosis according to the revised World Health Organization criteria or post-essential thrombocythemia-MF or post-polycythemia vera-MF according to the IWG-MRT criteria
Dynamic International Prognostic Scoring System intermediate-2 or high-risk MF
Refractory to JAK-inhibitor treatment as defined in either inclusion (i) or (ii)
(i) Treatment with JAK-inhibitor for >= 6 months duration, including at least
months at an optimal dose as assessed by the investigator for that
participant and one of the
following
no decrease in spleen volume (< 10% by MRI or CT) from the start of treatment with JAK-inhibitor
no decrease in spleen size (< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor
no decrease in symptoms (< 20% by MFSAF or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor)
a score of at least 15 on TSS assessed using the MFSAF v4.0 during screening
(ii) Treatment with JAK-inhibitor treatment for >= 3 months duration with
maximal doses (e.g., 20-25 mg twice daily ruxolitinib) for that participant
and no decrease in spleen volume/size or symptoms as defined in inclusion
criterion (i [a, b, or c])
Measurable splenomegaly demonstrated by a palpable spleen measuring >= 5 cm below the left costal margin or a spleen volume >= 450 cm^3 by MRI or CT
Active symptoms of MF on the MFSAF v4.0 demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale)
Hematology laboratory test values within the protocol defined limits
Biochemical laboratory test values must be within protocol defined limits
Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
Participants should follow protocol defined contraceptives procedures
A woman of childbearing potential must have a negative serum or urine pregnancy test at screening

Exclusion Criteria

Peripheral blood blast count of >= 10% or bone marrow blast count of >=10%
Known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
Prior treatment with imetelstat
Any chemotherapy or MF directed therapy, including investigational drug regardless of class or mechanism of action, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 mg/day prednisone or equivalent, and JAK-inhibitor treatment less than equal to 14 days prior to randomization
Diagnosis or treatment for malignancy other than MF except
Malignancy treated with curative intent and with no known active disease present for >= 3 years before randomization
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Known history of human immunodeficiency virus or any uncontrolled active systemic infection requiring IV antibiotics
Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), or any known acute or chronic liver disease unless related to underlying hepatosplenomegaly due to MF
Major surgery within 28 days prior to randomization
Any life-threatening illness (e.g., coronavirus disease-2019), medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the imetelstat metabolism, or put the study outcomes at undue risk
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