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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 Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML), sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06548230: Recruiting Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML), sponsored by M.D. Anderson Cancer Center.
NCT06548230 is a Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 84-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06548230, a Phase 1 study of Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML), 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.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Nadunolimab
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 1 |
What NCT06548230 shows while recruiting
NCT06548230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 84-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (52% lower).
The record links to 2 conditions, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06548230 reports a single indexed study location in 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: Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML).
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.
Learn More About Clinical Trials
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Where NCT06548230's enrollment target sits among peer trials
40 10th of 19 higher than 9 of 19 other Myelodysplastic Syndrome (MDS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome (MDS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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