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NCT04835584 · ClinicalTrials.gov registry record · Phase 1

KRT-232 and TKI Study in Chronic Myeloid Leukemia

A Phase 1 study of Chronic Myeloid Leukemia, sponsored by Kartos Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
109
Enrollment target
20
Study locations

NCT04835584 is a Phase 1 study of Chronic Myeloid Leukemia that is actively recruiting participants, run by Kartos Therapeutics. The registered enrollment target is 109 participants, below the 207-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT04835584, a Phase 1 study of Chronic Myeloid Leukemia, is actively recruiting participants, sponsored by Kartos Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
109 participants
Enrollment target
20
Study locations

Study Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

Conditions Studied

Interventions

  • DRUG Dasatinib
  • DRUG KRT-232
  • DRUG Nilotinib

Study Locations (20)

Other

  • Centre Leon Berard - Lyon
  • APHM Hopital de la Timone - Marseille
  • Institut Paoli-Calmettes - Marseille
  • Centre Hospitalier Lyon Sud - Saint-Genis-Laval
  • Azienda Ospedaliero - Universitaria Mater Domini - Catanzaro
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - Meldola FC
  • Fondazione IRCCS Policlinico San Matteo - Pavia
  • Pratia Onkologia Katowice - Katowice
  • National Medical Research Center of Hematology - Moscow
  • Almazov National Medical Research Center - Saint Petersburg
  • Samara State Medical University - Samara
  • Kyungpook National University Hospital - Daegu
  • Samsung Medical Center - Seoul

Alabama

  • University of Alabama Birmingham - Birmingham

Georgia

  • Georgia Cancer Center at Augusta University - Augusta

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Texas

  • Texas Oncology- Sammons CC at Baylor - Dallas

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Ontario

  • Princess Margaret Cancer Center - Toronto

MI

  • Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda - Milan

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2021-05-07
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Kartos Therapeutics

8 total trials

What the Registry Record Tells You About NCT04835584

The ClinicalTrials.gov registry entry for NCT04835584 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (47% lower). The listed sponsor is Kartos Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Dasatinib is the first listed.

NCT04835584 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Alabama, Georgia.

Frequently Asked Questions

What is clinical trial NCT04835584 about?

NCT04835584 is a clinical study titled "KRT-232 and TKI Study in Chronic Myeloid Leukemia". This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the e...

What is the current status of trial NCT04835584?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2021-05-07. Estimated completion is 2026-06-30.

What conditions does trial NCT04835584 study?

This clinical trial studies the following conditions: Chronic Myeloid Leukemia.

What interventions are being tested in trial NCT04835584?

The interventions under investigation include: Dasatinib (DRUG), KRT-232 (DRUG), Nilotinib (DRUG).

Who is sponsoring clinical trial NCT04835584?

This trial is sponsored by Kartos Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04835584 being conducted?

This trial has 20 study locations across Alabama, Georgia, Pennsylvania, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.