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Telomerase Inhibitor
Imetelstat for Myelodysplastic Syndrome
Phase 2 & 3
Waitlist Available
Research Sponsored by Geron Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during extension (up to approximately 3 years)
Awards & highlights
Study Summary
This trial is testing a new drug, imetelstat, to see if it works better than a placebo at treating anemia in people with myelodysplastic syndrome who have not responded to other treatments.
Who is the study for?
Adults over 18 with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) who need regular blood transfusions and haven't responded to standard treatments can join. They must have an ECOG performance status of 0, 1, or 2, indicating they are fully active or have some limitations but don't require full-time care.Check my eligibility
What is being tested?
The trial is testing Imetelstat's effectiveness in improving the condition of MDS patients who rely on blood transfusions after not responding to other treatments. Part of the group will receive Imetelstat while another part will get a placebo for comparison.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants should be aware that any new treatment like Imetelstat could cause unexpected reactions ranging from mild symptoms like nausea to more serious conditions affecting organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My MDS is classified as low or intermediate-1 risk.
Select...
I needed at least 4 blood transfusions in the last 2 months due to low hemoglobin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during extension (up to approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during extension (up to approximately 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Transfusion
Secondary outcome measures
Extension Phase: Number of Participants with Adverse Events (AEs)
Extension Phase: Overall Survival
Extension Phase: Progression Free Survival (PFS) Survival
+21 moreSide effects data
From 2018 Phase 2 trial • 80 Patients • NCT01731951100%
Diarrhoea
100%
Neutrophil count decreased
100%
Platelet count decreased
100%
White blood cell count decreased
89%
Fatigue
67%
Anaemia
44%
Blood alkaline phosphatase increased
44%
Hyperglycaemia
33%
Oedema peripheral
33%
Aspartate aminotransferase increased
33%
Cough
33%
Early satiety
22%
Abdominal pain
22%
Activated partial thromboplastin time prolonged
22%
Pain
22%
Lipase increased
22%
Hyperuricaemia
22%
Dyspnoea
22%
Alanine aminotransferase increased
22%
Hyperkalaemia
11%
Blood amylase increased
11%
Myalgia
11%
Pain in extremity
11%
Peripheral sensory neuropathy
11%
Lung infection
11%
Constipation
11%
Nausea
11%
Vomiting
11%
Chills
11%
Pyrexia
11%
Contusion
11%
Blood bilirubin increased
11%
Anorexia
11%
Bone pain
11%
Arthralgia
11%
Back pain
11%
Dizziness
11%
Hyperhidrosis
11%
Pruritus
11%
Epistaxis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm E: Imetelstat 7.5 - 9.4 mg/kg (MF [With Spliceosome Mutation or Ring Sideroblasts])
Arm F: Imetelstat 7.5 - 9.4 mg/kg (MF [Without Spliceosome Mutation and Ring Sideroblasts])
Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia
Arm G: Imetelstat 7.5 - 9.4 mg/kg (MDS/MPN or MDS With Spliceosome Mutations or Ring Sideroblasts)
Arm B: Imetelstat 9.4 mg/kg as Induction + Maintenance (MF)
Arm A: Imetelstat 9.4 mg/kg (MF)
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 (Ventricular Repolarization Substudy): ImetelstatExperimental Treatment1 Intervention
Imetelstat will be administered at a starting dose of 7.5 mg/kg given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Subjects receiving imetelstat who continue into the extension phase will continue to receive imetelstat treatment per this same schedule.
Group II: Part 2 (Main Study): ImetelstatExperimental Treatment1 Intervention
Imetelstat will be administered at a starting dose of 7.5 mg/kg given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Subjects receiving imetelstat who continue into the extension phase will continue to receive imetelstat treatment per this same schedule.
Group III: Part 1: ImetelstatExperimental Treatment1 Intervention
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
Group IV: Part 2 (Main Study): PlaceboPlacebo Group1 Intervention
Matching Placebo to Imetelstat will be administered.
Group V: Part 2 (Ventricular Repolarization Substudy): PlaceboPlacebo Group1 Intervention
Matching Placebo to Imetelstat will be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imetelstat
2012
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Geron CorporationLead Sponsor
18 Previous Clinical Trials
1,163 Total Patients Enrolled
Faye Feller, MDStudy DirectorGeron Corporation
2 Previous Clinical Trials
187 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high-dose steroids or growth factors in the last 4 weeks.I haven't taken any cancer or immune system treatments in the last 4 weeks.I have a long-term irregular heartbeat.You are allergic to imetelstat or any of its ingredients.Your heart rate is either too slow (less than 50 beats per minute) or too fast (more than 100 beats per minute) when you are not active or exercising.My family has a history of long QT syndrome.I haven't had serious heart issues or strokes in the last year.I am 18 years old or older.I have been diagnosed with MDS or MDS/MPN-RS-T by a bone marrow test in the last 12 weeks.I can take care of myself and am up and about more than half of my waking hours.I have not used any experimental drugs or devices in the last 30 days.I have previously been treated with drugs like azacitidine or lenalidomide.My family has a history of sudden heart-related deaths that may be genetic.I have had chest surgery that may affect my heart's electrical signals.My blood pressure is controlled and does not exceed 160/100 mmHg.My MDS is classified as low or intermediate-1 risk.I have or might have long QT syndrome.I have been treated with imetelstat before.I needed at least 4 blood transfusions in the last 2 months due to low hemoglobin.I have a history of a serious type of heart block.I am not on medications that affect heart rhythm.I have a history of significant heart rhythm problems.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 (Ventricular Repolarization Substudy): Imetelstat
- Group 2: Part 1: Imetelstat
- Group 3: Part 2 (Main Study): Imetelstat
- Group 4: Part 2 (Main Study): Placebo
- Group 5: Part 2 (Ventricular Repolarization Substudy): Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for people who want to partake in this research?
"Yes, 278 patients are needed for this clinical trial that is currently running at 8 different locations. The study was first posted on 11/24/2015, as indicated by the data on clinicaltrials.gov, and was last updated on 10/14/2022."
Answered by AI
Could you please list the number of active sites for this trial?
"There are 11 total enrolment sites for this clinical trial, which include Princess Margaret Hospital in Toronto, Ontario, Acrc/Arizona Clinical Research, Inc. in Tucson, Arizona, and Jewish General Hospital in Montréal, Quebec."
Answered by AI
Can you tell us about other times Imetelstat has been studied?
"Imetelstat was first studied in 2015. Out of the 18245 completed clinical trials, 2 are currently recruiting patients. Many of these trials are taking place in Toronto, Canada."
Answered by AI
What are the predecessors of this research?
"At present, there are two ongoing clinical trials for Imetelstat spanning 148 cities and 31 countries. The first study of Imetelstat was conducted in 2015 and completed its Phase 2 & 3 drug approval process. This trial, sponsored by Geron Corporation, enrolled 278 patients. In the years since 2015, a total of 18,245 clinical trials have been completed."
Answered by AI
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