OncoMatch/Clinical Trials/NCT07008638
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)
Is NCT07008638 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Bortezomib and CPX-351 for acute myeloid leukemia.
Treatment: Bortezomib · CPX-351 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: TP53 mutation
Prior therapy
Cannot have received: systemic chemotherapy
Exception: hydroxyurea and leukapheresis to control excess peripheral blasts is permissible
Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is permissible.
Lab requirements
Kidney function
An estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
Liver function
AST and ALT ≤3 x ULN, ALP ≤2.5 x ULN, and total bilirubin ≤1.5 x ULN. (exception for Gilbert's syndrome or leukemic infiltration of liver)
Cardiac function
NYHA Class I or II, left ventricular ejection fraction > 50% by echocardiogram, MUGA or cardiac MRI
Adequate renal, hepatic and cardiac function defined as: Renal: An estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; Hepatic: AST and ALT ≤3 x ULN, ALP ≤2.5 x ULN, and total bilirubin ≤1.5 x ULN. (exception for Gilbert's syndrome or leukemic infiltration of liver); Cardiac: New York Heart Association (NYHA) Class I or II, left ventricular ejection fraction > 50% by echocardiogram, MUGA or cardiac MRI
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Masonic Cancer Center · Minneapolis, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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