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RECRUITING Phase 1

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

NCT05371964 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Ruxolitinib
  • DRUG Imetelstat sodium

Study Locations (8)

California

  • City of Hope — Duarte
  • City of Hope — Irvine

Florida

  • University of Miami — Coral Gables
  • H. Lee Moffitt Cancer Center and Research Institute, Inc. — Tampa

Texas

  • Texas Oncology — Denison
  • Texas Oncology — Tyler

New York

  • Icahn School of Medicine at Mount Sinai — New York

Washington

  • Fred Hutchinson Cancer Center — Seattle

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-05-04
Est. Completion 2028-08
Phase Phase 1

Sponsor

Geron Corporation

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05371964

The ClinicalTrials.gov registry entry for NCT05371964 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Geron Corporation, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Myelofibrosis appearing as the primary indexed condition, and to 2 interventions — of which Ruxolitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05371964 reports 8 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05371964 about?

NCT05371964 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis". 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 ruxolit...

What is the current status of trial NCT05371964?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-05-04. Estimated completion is 2028-08.

What conditions does trial NCT05371964 study?

This clinical trial studies the following conditions: Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05371964?

The interventions under investigation include: Ruxolitinib (DRUG), Imetelstat sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05371964?

This trial is sponsored by Geron Corporation, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05371964 being conducted?

This trial has 8 study locations across California, Florida, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial