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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: Recruiting Phase 1 study of Acute Myeloid Leukemia and TP53, sponsored by Masonic Cancer Center, University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the CR rate of bortezomib + CPX-351 for the treatment of TP53m AML.
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG CPX-351
Study Locations (1)
Minnesota
- Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2028-01-27 |
| Phase | Phase 1 |
What NCT07008638 shows while recruiting
NCT07008638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (72% lower).
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 a single indexed study location in 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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Where NCT07008638's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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