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NCT04774393 · ClinicalTrials.gov registry record · Phase 1

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

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
84
Enrollment target
1
Study location

NCT04774393 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 84 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04774393, 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
84 participants
Enrollment target
1
Study location

Study Summary

This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Enasidenib and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine/cedazuridine and venetoclax in combination with ivosidenib or enasidenib may help control acute myeloid leukemia.

Conditions Studied

Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia

Interventions

  • DRUG Venetoclax
  • DRUG Decitabine and Cedazuridine
  • DRUG Ivosidenib
  • DRUG Enasidenib

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2021-05-24
Est. Completion 2027-11-29
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 NCT04774393

The ClinicalTrials.gov registry entry for NCT04774393 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 84 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 (28% 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 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.

NCT04774393 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04774393 about?

NCT04774393 is a clinical study titled "Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia". This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX...

What is the current status of trial NCT04774393?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-05-24. Estimated completion is 2027-11-29.

What conditions does trial NCT04774393 study?

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

What interventions are being tested in trial NCT04774393?

The interventions under investigation include: Venetoclax (DRUG), Decitabine and Cedazuridine (DRUG), Ivosidenib (DRUG), Enasidenib (DRUG).

Who is sponsoring clinical trial NCT04774393?

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

Where is trial NCT04774393 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.