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 not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Rozpoznana białaczka ostra (AML) z mutacją TP53, bez poprzedniego leczenia chemioterapią
- •Ogólny stan zdrowotny wystarczający do leczenia (wynik Karnofsky'ego co najmniej 70)
- •Prawidłowa funkcja nerek (GFR co najmniej 30)
- •Prawidłowa funkcja wątroby i serca (frakcja wyrzutowa serca powyżej 50%)
- •Chęć stosowania antykoncepcji przez co najmniej 7 miesięcy po ostatniej dawce leku (dla osób w wieku rozrodczym)
- •Dobrowolna zgodna na uczestnictwo w badaniu
✗ Disqualifies
- •Poprzednie leczenie chemioterapią na białaczkę ostrą
- •Inne typy białaczki ostrych (oprócz AML z mutacją TP53)
- •Białaczka z zajęciem ośrodkowego układu nerwowego
- •Aktywna lub niekontrolowana infekcja HIV, zapalenie wątroby B lub C
- •Poważne problemy z sercem (zawał w ostatnich 6 miesiącach, arytmia, niewydolność serca)
- •Inne nowotwory w ostatnim roku
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Masonic Cancer Center
Minneapolis, United States
Trial contact
Joseph Norton, DO
Zohar Sachs, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/23/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.