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NCT04195945 · ClinicalTrials.gov registry record · Phase 2

CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients

A Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm, sponsored by Fred Hutchinson Cancer Center.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT04195945 is a Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04195945, a Phase 2 study of Acute Myeloid Leukemia and Myeloid Neoplasm, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, cladribine, cytarabine, G-CSF, and mitoxantrone, 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. Giving CPX-351 or the CLAG-M regimen at doses typically used for medically-fit patients with acute myeloid leukemia may work better than reduced doses of CPX-351 in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms.

Interventions

  • DRUG Cladribine
  • BIOLOGICAL Recombinant Granulocyte Colony-Stimulating Factor
  • DRUG Cytarabine
  • DRUG Liposome-encapsulated Daunorubicin-Cytarabine
  • DRUG Mitoxantrone

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2020-03-11
Est. Completion 2027-12-31
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT04195945

The ClinicalTrials.gov registry entry for NCT04195945 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 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 (48% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cladribine is the first listed.

NCT04195945 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT04195945 about?

NCT04195945 is a clinical study titled "CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients". This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, c...

What is the current status of trial NCT04195945?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-03-11. Estimated completion is 2027-12-31.

What conditions does trial NCT04195945 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myeloid Neoplasm.

What interventions are being tested in trial NCT04195945?

The interventions under investigation include: Cladribine (DRUG), Recombinant Granulocyte Colony-Stimulating Factor (BIOLOGICAL), Cytarabine (DRUG), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG), Mitoxantrone (DRUG).

Who is sponsoring clinical trial NCT04195945?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04195945 being conducted?

This trial has 1 study location across Washington. 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

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