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NCT07008638 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)

A Phase 1 study of Acute Myeloid Leukemia and TP53, sponsored by Masonic Cancer Center, University of Minnesota.

Recruiting
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT07008638 is a Phase 1 study of Acute Myeloid Leukemia and TP53 that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 32 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07008638, a Phase 1 study of Acute Myeloid Leukemia and TP53, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.

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

Study Summary

This is a Phase I/II study evaluating safety and efficacy of proteasome inhibitor (bortezomib) in combination with CPX-351 (liposomal daunorubicin and cytarabine) for the treatment of newly-diagnosed TP53-mutated acute myeloid leukemia (TP53m AML). The primary endpoint of the study is to define safety/tolerability (phase I) and preliminary efficacy profile (phase II) of the treatment. The secondary endpoints of interest are complete remission (CR) rate, detectable minimal residual disease (MRD) status, overall response rate (ORR), rate of allogeneic hematopoietic cell transplantation (allo-HCT), treatment-related mortality (TRM), overall survival (OS), achievement of complete remission anytime in 1 year, and disease-free survival (DFS) at 1 year and 2 years. All the patient outcomes assessments will be performed as part of standard-of-care AML management. The hypothesis is the combination of bortezomib and CPX-351 will have an acceptable safety profile in this patient population based on the data from previous studies. The treatment will attenuate Nuclear Factor kB pathway activation in these cells and eradicate TP53m leukemia stem cells (LSC) leading to increased response rate and survival in these patients.

Conditions Studied

Acute Myeloid Leukemia TP53

Interventions

  • DRUG Bortezomib
  • DRUG CPX-351

Study Locations (1)

Minnesota

  • Masonic Cancer Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2025-07-07
Est. Completion 2028-01-27
Phase Phase 1

Sponsor

Masonic Cancer Center, University of Minnesota

249 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07008638

The ClinicalTrials.gov registry entry for NCT07008638 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 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 (72% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 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 2 interventions - of which Bortezomib is the first listed.

NCT07008638 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT07008638 about?

NCT07008638 is a clinical study titled "Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)". This is a Phase I/II study evaluating safety and efficacy of proteasome inhibitor (bortezomib) in combination with CPX-351 (liposomal daunorubicin and cytarabine) for the treatment of newly-diagnosed TP53-mutated acute myeloid leukemia (TP53m AML). The primary endpoint of the study is to define saf...

What is the current status of trial NCT07008638?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-07-07. Estimated completion is 2028-01-27.

What conditions does trial NCT07008638 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, TP53.

What interventions are being tested in trial NCT07008638?

The interventions under investigation include: Bortezomib (DRUG), CPX-351 (DRUG).

Who is sponsoring clinical trial NCT07008638?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07008638 being conducted?

This trial has 1 study location across Minnesota. 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.