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Telomerase Inhibitor

Imetelstat + Ruxolitinib for Myelofibrosis

Phase 1

Recruiting

Research Sponsored by Geron Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for ruxolitinib treatment: Part 1 participants only must be 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 only must be a candidate for ruxolitinib treatment as assessed by the investigator and has not previously been treated with a JAK inhibitor

Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of imetelstat treatment up to approximately 5 years

Awards & highlights

Study Summary

This trial is studying the recommended dosage of a combination of imetelstat and ruxolitinib to treat myelofibrosis, as well as the safety and effectiveness of this dosage.

Who is the study for?

This trial is for adults with a condition called myelofibrosis, who are either already on ruxolitinib treatment or haven't been treated with JAK inhibitors. They should have symptoms like an enlarged spleen or other related issues and must not be candidates for stem cell transplant. Participants need to meet certain blood and biochemical test criteria, have a performance status score of 0-2, and agree to use contraception.Check my eligibility

What is being tested?

The study tests the combination of two drugs: Imetelstat and Ruxolitinib in people with myelofibrosis. The first part determines the best dose of Imetelstat when used with Ruxolitinib, while the second part assesses safety and how well this combined dose works.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, changes in blood counts leading to increased risk of infections or bleeding, liver problems, fatigue, shortness of breath, gastrointestinal issues such as nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with a type of myelofibrosis according to specific health criteria.

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My myelofibrosis is classified as intermediate-1, intermediate-2, or high-risk.

Select...

I have symptoms or an enlarged spleen due to myelofibrosis.

Select...

I cannot or do not want to have a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of imetelstat treatment up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of imetelstat treatment up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of imetelstat treatment up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Incidence, Type, and Severity of Adverse Events, Including Dose-limiting Toxicity (DLT) During the DLT Observation Period and/or Study Treatment

Part 2: Number of Participants With Treatment-emergent Adverse Event (AE)

Part 2: Symptom Response Rate at Week 24

Secondary outcome measures

Part 1 and 2: Duration of Response (DOR) Per IWG-MRT Criteria

Part 1 and 2: Imetelstat and Ruxolitinib Exposure From Time Zero to Last Measurable Concentration (AUC0-t)

Part 1 and 2: Percentage of Participants With Complete Remission (CR), Partial Remission (PR), Clinical Improvement (CI) Per the Modified 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Criteria

+10 more

Side effects data

From 2018 Phase 2 trial • 80 Patients • NCT01731951

100%

Neutrophil count decreased

100%

Platelet count decreased

100%

White blood cell count decreased

89%

Fatigue

89%

Diarrhoea

89%

Anaemia

78%

Hyperglycaemia

78%

Dyspnoea

67%

Nausea

67%

Oedema peripheral

67%

Abdominal pain

56%

Activated partial thromboplastin time prolonged

44%

Pyrexia

44%

Aspartate aminotransferase increased

44%

Hypocalcaemia

44%

Cough

44%

Blood creatinine increased

44%

Alanine aminotransferase increased

44%

Anorexia

33%

Pain

33%

Sepsis

33%

Blood alkaline phosphatase increased

33%

Pain in extremity

33%

Hypotension

33%

Lung infection

33%

Early satiety

33%

Lipase increased

33%

Hyponatraemia

33%

Dizziness

33%

Hypoglycaemia

22%

Blood amylase increased

22%

Sinus tachycardia

22%

Chills

22%

Hyperkalaemia

22%

Hyperuricaemia

22%

Hypokalaemia

22%

Arthralgia

22%

Insomnia

22%

Atrial fibrillation

22%

Myalgia

22%

Alopecia

22%

Sinusitis

22%

Hypernatraemia

11%

Epistaxis

11%

Blood bilirubin increased

11%

Neck pain

11%

Peripheral sensory neuropathy

11%

Vomiting

11%

Non-cardiac chest pain

11%

Contusion

11%

Night sweats

11%

Abdominal distension

11%

Back pain

11%

Anxiety

11%

Haematoma

11%

Eye disorders

11%

Constipation

11%

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Arm D: Imetelstat 9.4 mg/kg (Blast-phase MF/Acute Myeloid Leukemia

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 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

1Treatment groups

Experimental Treatment

Group I: Imetelstat + RuxolitinibExperimental Treatment2 Interventions

Part 1: Participants who have received ruxolitinib orally (PO) as part of standard of care (SOC) for at least 12 weeks prior to Screening will be enrolled. After enrollment, participants will initiate imetelstat therapy. Dose levels of imetelstat may include 4.7, 6, 7.5, 9.4mg, until a RP2D is established. Part 2: Janus kinase (JAK) inhibitor naïve participants will receive initial treatment with ruxolitinib for at least 12 weeks, including 4 weeks at a stable dose, followed by imetelstat treatment at the RP2D in combination with ruxolitinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

Imetelstat

2012

Completed Phase 2

~100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Geron CorporationLead Sponsor

18 Previous Clinical Trials

1,411 Total Patients Enrolled

Tymara Berry, MDStudy DirectorGeron Corporation

Media Library

Imetelstat (Telomerase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05371964 — Phase 1

Myelofibrosis Research Study Groups: Imetelstat + Ruxolitinib

Myelofibrosis Clinical Trial 2023: Imetelstat Highlights & Side Effects. Trial Name: NCT05371964 — Phase 1

Imetelstat (Telomerase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371964 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are partaking in this trial's treatments?

"Affirmative. The clinical trial data available on clinicaltrials.gov indicates that this medical experiment, first launched on May 4th 2022, is actively looking for participants to join its ranks. This study requires 41 people and 3 separate sites in total."

Answered by AI

Are any recruitment opportunities available for this clinical trial currently?

"Affirmative. Per the information accessible on clinicaltrials.gov, this medical study is presently looking for participants and was initially posted on May 4th 2022. The trial has since been updated to accept up to 41 patients from three different sites."

Answered by AI

Is Imetelstat a viable solution in terms of patient safety?

"Imetelstat has only been tested in a Phase 1 trial, so its safety is rated as a score of one. This indicates that there is limited evidence to support the drug's efficacy and security profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05371964.

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