BridgeMD
Tests treatment safety and results for Myelofibrosis
Official title A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
ClinicalTrials.gov ID: NCT05371964
What this study is testing
What is Imetelstat sodium?
Imetelstat sodium is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myelofibrosis.
Also referred to as GRN163L.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of primary myelofibrosis (PMF) according to the revised World Health Organization (WHO) criteria or post-essential thrombocythemia-MF or...
- 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...
- Part 2 participants: Candidate for ruxolitinib treatment as assessed by the investigator and has not previously been treated with a JAK inhibitor...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Coral Gables, Florida, United States
- Tampa, Florida, United States
- New York, New York, United States
- Denison, Texas, United States
- Tyler, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Coral Gables, Florida, United States; Tampa, Florida, United States; New York, New York, United States; Denison, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.