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New treatment option for Acute Myeloid Leukemia
Official title 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)
ClinicalTrials.gov ID: NCT07008638
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult (age ≥ 18 years at time of consent)
- Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is...
- Karnofsky performance status (KPS) ≥ 70
- Adequate renal, hepatic and cardiac function defined as
- Renal: An estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
You likely can't join if
- Received systemic chemotherapy for the treatment of AML
- Bi-phenotypic acute leukemia or mixed lineage leukemia, acute promyelocytic leukemia
- Active central nervous system malignancy or symptoms of CNS involvement
- Symptomatic extramedullary disease
- Known history of uncontrolled HIV or active hepatitis B or active hepatitis C infection
- Has any of the following cardiac abnormalities
See the full eligibility criteria
- Adult (age ≥ 18 years at time of consent)
- Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is permissible. WBC \< 25,000 to initiate bortezomib, must reach this...
- Karnofsky performance status (KPS) ≥ 70
- 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
- Sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
- Provides voluntary written consent before the performance of any study related activities not part of standard of care.
- Received systemic chemotherapy for the treatment of AML
- Bi-phenotypic acute leukemia or mixed lineage leukemia, acute promyelocytic leukemia
- Active central nervous system malignancy or symptoms of CNS involvement
- Symptomatic extramedullary disease
- Known history of uncontrolled HIV or active hepatitis B or active hepatitis C infection
- Has any of the following cardiac abnormalities
- Symptomatic congestive heart failure
- Myocardial infarction less than or equal to 6 months prior to enrollment
- Unstable angina pectoris
- Serious uncontrolled cardiac arrhythmia
- Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent. Potential participants with adequately resected basal or squamous cell carcinoma of the...
- Participants for whom administration of CPX-351 would exceed their lifetime cumulative daunorubicin exposure limit of 550 mg/m2 (or 400 mg/m2 in patients with prior chest radiation) or equivalent anthracycline dose.
- Pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.