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NCT06548230 · ClinicalTrials.gov registry record · Phase 1

A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

A Phase 1 study of Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome(MDS), sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT06548230 is a Phase 1 study of Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome(MDS) that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 48-participant average among 6 other Acute Myelogenous Leukemia (AML) trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06548230, a Phase 1 study of Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome(MDS), is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

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

Study Summary

To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Nadunolimab

Study Locations (1)

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-03-05
Est. Completion 2029-12-01
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT06548230

The ClinicalTrials.gov registry entry for NCT06548230 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 48-participant average among 6 other Acute Myelogenous Leukemia (AML) trials with a reported enrollment target (17% 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 2 conditions, with Acute Myelogenous Leukemia (AML) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT06548230 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT06548230 about?

NCT06548230 is a clinical study titled "A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)". To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatmen...

What is the current status of trial NCT06548230?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-03-05. Estimated completion is 2029-12-01.

What conditions does trial NCT06548230 study?

This clinical trial studies the following conditions: Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome(MDS).

What interventions are being tested in trial NCT06548230?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Nadunolimab (DRUG).

Who is sponsoring clinical trial NCT06548230?

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

Where is trial NCT06548230 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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