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Phase IB/II of CPX-351 for Relapse Prevention in AML | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Phase IB/II of CPX-351 for Relapse Prevention in AML

Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation

NCT04990102•Georgetown University

Summary

This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Newly diagnosed patients \> 18 years of age
•Patients must be in CR or CRh (complete remission with partial count recovery).
•Must have received ANY induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax, for up to 6 cycles or no more than one year of treatment.
•Must be able to start therapy within 3 months of last documented CR
•De novo or secondary AML/treatment related AML (non-M3) including AML with myelodysplasia-related changes (MRC), histologically confirmed
•Patients must be ineligible for allogeneic BMT (for any reason including poor performance status, patient's preference, favorable AML not a candidate for transplant, or comorbidities and age precluding from transplant etc)
•Cardiac ejection fraction ≥ 50% by transthoracic echocardiography or MUGA scan
•Adequate hepatic and renal function defined as:
•* Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)
•* Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 is permissible if due to disease.
+5 more criteria

Exclusion Criteria

•Prior allogeneic transplant
•Previous cumulative anthracycline (doxorubicin equivalent) dose equal to or greater than 345 mg/m2, and for patients with prior mediastinal XRT, anthracycline dose equal to or greater than 295 mg/m2
•Acute promyelocytic leukemia \[t(15;17)\]
•If patient is unable to sign informed consent due to any serious medical condition, laboratory abnormality or psychiatric illness
•Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)
•History of Wilson's disease or other copper-related disorders
•History of allergic reactions attributed to compounds of similar composition to cytarabine and daunorubicin or liposomal products
•History of other malignancies, except:
•* Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
•* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
+13 more criteria

Locations (3)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

May 22, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

July 29, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia (AML) in Remission

Interventions

CPX-351

DRUG

Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients

NCT04314219

Acute Lymphoblastic Leukemia (ALL) in Complete RemissionAcute Myeloid Leukemia (AML) in Remission

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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