A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

Study CPX351-103 is an open-label, multicenter, phase 1b, safety and PK study to determine the MTD of the combination of CPX 351 and venetoclax when administered to subjects with newly diagnosed AML who are unfit for intensive chemotherapy (ICT) and to determine the recommended phase 2 dose (RP2D) for the Expansion Phase. This study will comprise 2 phases: a Dose Exploration Phase (Part 1) and an Expansion Phase (Part 2), in which all subjects will receive a combination of CPX-351 and venetoclax.

Key facts

Study ID

NCT04038437

Run by

Jazz Pharmaceuticals

People needed

35

Starts

2019-10-15

Expected to finish

2022-09-24

Last updated by the study team

2022-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have newly diagnosed AML with histological confirmation by World Health Organization (WHO) criteria.
• Definition of subjects who are unfit for ICT:
• Each subject must meet the following criteria characterizing him / her as unfit to receive ICT prior to the first day of therapy to be enrolled in the study:
• ≥ 75 years of age OR
• ≥ 18 to 74 years of age and fulfilling at least 1 criteria associated with lack of fitness for ICT as follows:
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 to 3;
• Cardiac history of Congestive Heart Failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤ 50%.
• Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ≤ 65% or Forced Expiratory Volume in 1 second (FEV1) ≤ 65%;
• Creatinine clearance (CrCl) ≥ 30 mL/min to < 45 mL/min calculated by the Cockcroft-Gault formula;
• Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × Upper Limit of Normal (ULN);
• Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment.
• In addition, all subjects must meet the following criteria:
• If the subject is ≥ 75 years of age, then ECOG Performance Status must be 0-2.
• Subject must have adequate renal function as demonstrated by a CrCl ≥ 30 mL/min (calculated by the Cockcroft Gault formula or measured by 24-hour urine collection).
• Subject must have adequate liver function as demonstrated by:
• Aspartate aminotransferase (AST) ≤ 3.0 × ULN*
• Alanine aminotransferase (ALT) ≤ 3.0 × ULN*
• Bilirubin ≤ 1.5 × ULN (subjects who are < 75 years of age may have bilirubin of ≤ 3.0 × ULN)* *Unless considered to be due to leukemic organ involvement.
• Female subjects must be either postmenopausal defined as:
• Age > 55 years with no menses for ≥ 2 years without an alternative medical cause.
• OR
• Age ≤ 55 years with no menses for ≥ 12 months without an alternative medical cause AND a follicle-stimulating hormone level > 40 IU/L;
• OR
• Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR
• A woman of childbearing potential practicing at least 1 protocol specified method of birth control starting at Study Day 1 through at least 6 months after the last dose of study treatment.

You may not qualify if…

• Subject has ECOG Performance Status > 3, regardless of age.
• Subject has known Human Immunodeficiency Virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). HIV testing will be performed at Pretreatment, if required per local guidelines or institutional standards.
• Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.

Where it is running

• City of Hope — Duarte, California, United States
• Blood & Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Dana Farber/ Brigham & Women's Cancer Center — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Oregon Health & Science University — Portland, Oregon, United States
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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