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NCT04838041 · ClinicalTrials.gov registry record · Phase 2

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

A Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, sponsored by Medical College of Wisconsin.

Recruiting
Registry status
Phase 2
Development phase
51
Enrollment target
4
Study locations

NCT04838041 is a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 51 participants, roughly in line with the 53-participant average among 9 other Chronic Phase Chronic Myelogenous Leukemia trials with a reported enrollment target. The trial reports 4 study locations across 4 states.

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The verdict

NCT04838041, a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, is actively recruiting participants, sponsored by Medical College of Wisconsin.

RECRUITING
Registry status
Phase 2
Development phase
51 participants
Enrollment target
4
Study locations

Study Summary

This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.

Conditions Studied

Chronic Phase Chronic Myelogenous Leukemia

Interventions

  • DRUG Nilotinib
  • DRUG Imatinib
  • DRUG Asciminib 40 MG
  • DRUG Asciminib 40 MG Twice Daily
  • DRUG Asciminib 80 MG daily

Study Locations (4)

Michigan

  • The Barbara Ann Karmanos Cancer Institute - Detroit

New York

  • Memorial Sloan Kettering Cancer Center - New York

Utah

  • Huntsman Cancer Institute - Salt Lake City

Wisconsin

  • Froedtert Hospital & the Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2021-11-11
Est. Completion 2029-07
Phase Phase 2

Sponsor

Medical College of Wisconsin

447 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04838041

The ClinicalTrials.gov registry entry for NCT04838041 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 53-participant average among 9 other Chronic Phase Chronic Myelogenous Leukemia trials with a reported enrollment target. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Phase Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Nilotinib is the first listed.

NCT04838041 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Michigan, New York, Utah.

Frequently Asked Questions

What is clinical trial NCT04838041 about?

NCT04838041 is a clinical study titled "Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation". This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restar...

What is the current status of trial NCT04838041?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-11-11. Estimated completion is 2029-07.

What conditions does trial NCT04838041 study?

This clinical trial studies the following conditions: Chronic Phase Chronic Myelogenous Leukemia.

What interventions are being tested in trial NCT04838041?

The interventions under investigation include: Nilotinib (DRUG), Imatinib (DRUG), Asciminib 40 MG (DRUG), Asciminib 40 MG Twice Daily (DRUG), Asciminib 80 MG daily (DRUG).

Who is sponsoring clinical trial NCT04838041?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04838041 being conducted?

This trial has 4 study locations across Michigan, New York, Utah, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.