CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old

STATUS

Recruiting
participants needed

46
sponsor

Roswell Park Cancer Institute

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Updated on 19 February 2024

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cancer

ejection fraction

myeloid leukemia

cytarabine

myelodysplasia

daunorubicin

leukemia

chronic myelomonocytic leukemia

secondary acute myeloid leukemia

treatment related aml

treatment related acute myeloid leukemia

plasma creatinine

acute myeloid leukemia

myelodysplastic syndrome

aml

myelodysplastic syndrome acute myeloid leukemia

t-aml

acute myeloid leukemia with myelodysplasia-related changes

Summary

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This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Description

PRIMARY OBJECTIVE:

I. To determine the complete response rate including morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) as defined by the International Working Group Criteria.

SECONDARY OBJECTIVE:

I. To determine CR + CRi duration, event free survival (EFS), overall survival (OS), patients successfully proceeding to allogenic hematopoietic cell transplant, and adverse events (AE).

OUTLINE

INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.

RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and then every 3 months for up to 5 years.

Details

Condition	Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
Age	18years - 59years
Treatment	Liposome-encapsulated Daunorubicin-Cytarabine
Clinical Study Identifier	NCT04269213
Sponsor	Roswell Park Cancer Institute
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Newly diagnosed
	Therapy-related acute myeloid leukemia (AML)
	AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
	AML with MDS-related changes (as per World Health Organization [WHO])
	Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
	Plasma creatinine =< 1.5 x upper limit of normal (ULN)
	Total bilirubin < 2.0 mg/dL
	Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN
	Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >= 50%
	Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
	Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control
	Men must use a latex condom during any sexual contact with women of childbearing potential
	Willing to adhere to protocol specific requirements
	Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
	Prior treatment of AML
	Known clinically active central nervous system (CNS) leukemia
	Core-binding factor leukemia
	Acute promyelocytic leukemia
	Uncontrolled other malignancy
	Prior anthracycline exposure > 368 mg/m^2 of daunorubicin or equivalent
	Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
	Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs
	Human immunodeficiency virus (HIV) infection
	Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
	Evidence of ongoing, uncontrolled systemic infection
	Pregnant or breastfeeding women
	Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
	Received an investigational agent within 30 days prior to enrollment
	History of Wilson disease or other copper-handling disorders
	Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old