Coral Gables, FLNCT05371964Now EnrollingIRB Ready

Myelofibrosis Clinical Trial in Coral Gables, FL

Access cutting-edge myelofibrosis treatment through this clinical trial at a research site in Coral Gables. Study-provided care at no cost to qualified participants.

Sponsored by Geron Corporation

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Expert Care in Coral Gables

Access myelofibrosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related myelofibrosis treatment provided free

Apply for This Coral Gables Location

Check if you qualify for this myelofibrosis clinical trial in Coral Gables, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Coral Gables

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Coral Gables site if eligible
  4. 4Begin participation

About This Myelofibrosis Study in Coral Gables

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.

Sponsor: Geron Corporation

Who Can Participate

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: 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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Coral Gables?

Yes, this clinical trial (NCT05371964) has an active research site in Coral Gables, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myelofibrosis Treatment Options in Coral Gables, FL

If you're searching for myelofibrosis treatment options in Coral Gables, FL, this clinical trial (NCT05371964) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Coral Gables research site is actively enrolling participants for this clinical trial. You'll receive care from experienced myelofibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myelofibrosis clinical trials near you to find additional studies recruiting in your area.

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