RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

An Open Label, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Patients With Myelofibrosis

Quick Facts

Study Start:2022-05-04

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05371964

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: On ruxolitinib treatment for at least 12 weeks with at least 4 consecutive weeks immediately prior to enrollment at a stable dose. * Part 2 participants: Candidate for ruxolitinib treatment as assessed by the investigator and has not previously been treated with a JAK inhibitor (Cohort A) OR currently receiving ruxolitinib per standard of care for at least 12 weeks with at least 4 consecutive weeks at a stable dose prior to enrollment (Cohort B). Note that the study will no longer recruit participants into Cohort A. * Active symptoms of MF on the MFSAF v4.0 demonstrated by: * Part 1 participants only: At least 2 symptoms with a score ≥ 1 * Part 2 participants only: At least 2 symptoms with a score of ≥ 3, or a total score of at least 10. * 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.	* Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10%. * Prior treatment with JAK inhibitor (except for participants being dosed optimized on ruxolitinib treatment prior to screening and enrollment in part 1 or Part 2 Cohort B). * 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, (except for ruxolitinib for participants being dose optimized prior to enrollment), immunomodulatory or immunosuppressive therapy, corticosteroids \>30 mg/day prednisone or equivalent ≤14 days prior to enrollment. * Prior history of hematopoietic stem cell transplant. * 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.

Inclusion Criteria

Exclusion 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: On ruxolitinib treatment for at least 12 weeks with at least 4 consecutive weeks immediately prior to enrollment at a stable dose.
* Part 2 participants: Candidate for ruxolitinib treatment as assessed by the investigator and has not previously been treated with a JAK inhibitor (Cohort A) OR currently receiving ruxolitinib per standard of care for at least 12 weeks with at least 4 consecutive weeks at a stable dose prior to enrollment (Cohort B). Note that the study will no longer recruit participants into Cohort A.
* Active symptoms of MF on the MFSAF v4.0 demonstrated by:
* Part 1 participants only: At least 2 symptoms with a score ≥ 1
* Part 2 participants only: At least 2 symptoms with a score of ≥ 3, or a total score of at least 10.
* 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.

* Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10%.
* Prior treatment with JAK inhibitor (except for participants being dosed optimized on ruxolitinib treatment prior to screening and enrollment in part 1 or Part 2 Cohort B).
* 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, (except for ruxolitinib for participants being dose optimized prior to enrollment), immunomodulatory or immunosuppressive therapy, corticosteroids \>30 mg/day prednisone or equivalent ≤14 days prior to enrollment.
* Prior history of hematopoietic stem cell transplant.
* 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.

Contacts and Locations

Study Contact

Michelle Mudge-Riley, DO

CONTACT

650-473-7793

myf1001-info@geron.com

Judy Ho

CONTACT

650-473-7793

myf1001-info@geron.com

Principal Investigator

Michelle Mudge-Riley, DO

STUDY_DIRECTOR

Geron Corporation

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

City of Hope

Irvine, California, 92618

United States

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

Texas Oncology

Denison, Texas, 75020

United States

Texas Oncology

Tyler, Texas, 75702

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Geron Corporation

Michelle Mudge-Riley, DO, STUDY_DIRECTOR, Geron Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-04

Study Completion Date2028-08

Study Record Updates

Study Start Date2022-05-04

Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

Myelofibrosis