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NCT04047641 · ClinicalTrials.gov registry record · Phase 1

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
80
Enrollment target
1
Study location

NCT04047641 is a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04047641, a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.

Conditions Studied

Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia High Risk Myelodysplastic Syndrome Recurrent High Risk Myelodysplastic Syndrome Refractory High Risk Myelodysplastic Syndrome Recurrent Acute Biphenotypic Leukemia Blasts 20 Percent or More of Bone Marrow Nucleated Cells

Interventions

  • DRUG Cladribine
  • DRUG Cytarabine
  • DRUG Idarubicin
  • DRUG Quizartinib

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2019-10-22
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04047641

The ClinicalTrials.gov registry entry for NCT04047641 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cladribine is the first listed.

NCT04047641 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04047641 about?

NCT04047641 is a clinical study titled "Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory)...

What is the current status of trial NCT04047641?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2019-10-22. Estimated completion is 2027-12-31.

What conditions does trial NCT04047641 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, Recurrent High Risk Myelodysplastic Syndrome.

What interventions are being tested in trial NCT04047641?

The interventions under investigation include: Cladribine (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Quizartinib (DRUG).

Who is sponsoring clinical trial NCT04047641?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04047641 being conducted?

This trial has 1 study location across Texas. 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.