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Study Summary
This trial is testing a new drug for people with myelofibrosis who have not responded to other treatments. The goal is to see if it improves survival.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 80 Patients • NCT01731951Trial Design
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- My spleen has grown after JAK inhibitor treatment and I can't have more of this treatment.I have no active cancer except for treated skin cancer or cervical carcinoma in situ.I haven't taken any cancer drugs, steroids over 30 mg/day, or JAK inhibitors in the last 14 days.I am able to care for myself and perform daily activities.I have HIV or a current severe infection needing IV antibiotics.I have been diagnosed with a specific type of bone marrow disorder.I've been on a high-dose JAK-inhibitor for 3+ months without improvement in spleen size or symptoms.I've been on a JAK-inhibitor for 6+ months without improvement in spleen size or symptoms.I have been treated with imetelstat before.I have symptoms of myelofibrosis with a score of 5 or more.I have not had major surgery in the last 4 weeks.My spleen is enlarged, confirmed by a doctor's exam or imaging.I don't have any severe illnesses that could risk my safety in the study.My condition is considered high-risk by myelofibrosis standards.I do not have active hepatitis needing treatment or any liver disease needing treatment, unless it's due to myelofibrosis.My condition did not improve with JAK-inhibitor treatment and I cannot have a stem cell transplant.You are allergic or have had bad reactions to imetelstat or its ingredients.
- Group 1: Imetelstat
- Group 2: Best Available Therapy (BAT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we able to enroll patients in this clinical trial at the current time?
"That is accurate. The information available on clinicaltrials.gov affirms that this study, which was initially advertised on April 12th 2021, is still looking for patients to enroll. There are 320 participants needed in total and they will be recruited from 13 different locations."
Could you walk me through other studies that have used Imetelstat in the past?
"Since 2015, when imetelstat was first studied at Nottingham City Hospital - Clinical Haematology, there have been 17 completed clinical trials. Out of these, 2 are actively recruiting patients. A significant number of these studies are based in New york City."
Are there any foreseeable risks associated with Imetelstat?
"Imetelstat's safety is estimated to be a 3. This Phase 3 rating means that not only does efficacy have some supporting data, but there have been multiple rounds of tests affirming Imetelstat's safety."
How many test subjects are involved in this experiment?
"This study demands 320 individuals that fit the pre-established inclusion criteria. The sponsor, Geron Corporation, plans to run the trial from different locations including Weill Cornell Medical College and Gabrail Cancer Center."
Is this study popular in Canada?
"There are 13 clinical trial sites for this study, which can be found in cities such as New york, Canton and Durham. If you choose to participate in the trial, it may be helpful to select a location nearest you to reduce travel costs and time commitment."
What are the goals that researchers hope to achieve with this trial?
"The primary goal of this medical study, which will last for around three years, is to observe the participants' overall survival rates. Additionally, secondary objectives include measuring the maximum plasma concentration (Cmax), elimination half-life (t1/2), and reduction in bone marrow fibrosis."
How novel is this line of research?
"As of now, there are 2 ongoing Imetelstat clinical trials in 31 countries and 149 cities. The first trial began in 2015 and was sponsored by Geron Corporation. That initial study had 278 participants and completed Phase 2 & 3 drug approval. In the 5 years since then, 17 more studies have concluded."
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