Myeloproliferative Neoplasms Clinical Trial

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis

Summary

The purpose of the study is to identify the recommended Part 2 dose (R2PD) of imetelstat in combination with ruxolitinib in participants with myelofibrosis (MF) in Part 1, and to evaluate the safety and clinical activity of the R2PD of imetelstat in combination with ruxolitinib in participants with MF in Part 2.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of primary myelofibrosis (PMF) according to the revised World Health Organization (WHO) criteria or post-essential thrombocythemia-MF or post-polycythemia vera according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria
Dynamic International Prognostic Scoring System (DIPSS) intermediate-1, intermediate-2 or high-risk MF

Candidate for ruxolitinib treatment:

Part 1 participants only: On ruxolitinib treatment for at least 12 weeks (maximum of 24 weeks) with at least 4 consecutive weeks immediately prior to enrollment at a stable dose
Part 2 participants only: Not previously been treated with a JAK inhibitor

Clinical signs/symptoms of MF demonstrated by one of the following:

Measurable splenomegaly demonstrated by either 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
Ineligible for or unwilling to undergo hematopoietic stem cell transplant at time of study entry
Hematology laboratory test values within protocol defined limits
Biochemical laboratory test values 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%
Prior treatment with JAK inhibitor
Known allergies, hypersensitivity, or intolerance to imetelstat or ruxolitinib or excipients
Prior treatment with imetelstat
Major surgery within 28 days prior to enrollment
Any investigational drug regardless of class or mechanism of action, hydroxyurea, chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids >30 mg/day prednisone or equivalent ≤14 days prior to enrollment
Prior history of hematopoietic stem cell transplant
Prior history of partial or complete splenectomy

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 enrollment
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Clinically significant cardiovascular disease
Known history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection requiring IV antibiotics
Active systemic hepatitis infection requiring treatment or any known acute or chronic liver disease unless related to MF. Carriers of hepatitis virus are permitted to enter the study

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

41

Study ID:

NCT05371964

Recruitment Status:

Recruiting

Sponsor:

Geron Corporation

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There are 3 Locations for this study

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University of Miami
Coral Gables Florida, 33146, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa Florida, 33612, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

41

Study ID:

NCT05371964

Recruitment Status:

Recruiting

Sponsor:


Geron Corporation

How clear is this clinincal trial information?

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