Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.
1 other identifier
interventional
126
2 countries
28
Brief Summary
The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens. The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Typical duration for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
January 12, 2018
CompletedJanuary 12, 2018
October 1, 2017
1.7 years
November 10, 2008
September 3, 2017
December 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Complete Remission
Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of \>1000/µL and peripheral blood platelets of \>100,000/µL in the absence of bone marrow blasts.
Within 6 weeks of the last induction treatment
Secondary Outcomes (5)
Remission Duration/Time to Remission
Following achievement of CR over the study period
Event Free Survival
Up to 1 year from randomization
Overall Survival Rate at 1 Year
1 year
Rate of Stem Cell Transplant
Up to 1 year
Aplasia Rate
Day 14 (1st Induction)
Study Arms (2)
Arm A: CPX-351
EXPERIMENTALFirst induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
Arm B: Cytarabine + Daunorubicin
ACTIVE COMPARATORFirst induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥60 and \<76 years at the time of diagnosis of AML
- Pathological confirmation of AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Able to adhere to the study visit schedule and other protocol requirements
- Laboratory values fulfilling the following:
- Serum creatinine \< 2.0 mg/dL Serum total bilirubin \< 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase \< 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
- Cardiac ejection fraction \> 50% by echocardiography or MUGA scan
You may not qualify if:
- Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors \>5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for \>2 years before randomization are eligible)
- Prior treatment for AML; only hydroxyurea is permitted (see below)
- Acute promyelocytic leukemia \[t(15;17)\] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
- Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
- Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
- Clinical evidence of active CNS leukemia
- Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
- Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
- Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-related disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
University of California Medical Center
San Francisco, California, 94143, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Shands Jacksonville Medical Center
Jacksonville, Florida, 32209, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
Robert H.Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612-3861, United States
St.Francis Hospital
Beech Grove, Indiana, 46107, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Northern New Jersey Cancer Associates
Hackensack, New Jersey, 07601, United States
North Shore University Hospital
Manhasset, New York, 11020, United States
Weil Cornell Medical Center
New York, New York, 10021, United States
New York Medical College, Division of Oncology
Valhalla, New York, 10595, United States
Blumenthal Cancer Center/Mecklenburg Medical Group
Charlotte, North Carolina, 28204, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pittsburg Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79415, United States
Cancer Therapy and Research Center at the University of Texas
San Antonio, Texas, 78229, United States
Froedlert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
BC Cancer Research Center
Vancouver, British Columbia, V5Z 1L3, Canada
Queen Elisabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 2Y9, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
Related Publications (1)
Lancet JE, Cortes JE, Hogge DE, Tallman MS, Kovacsovics TJ, Damon LE, Komrokji R, Solomon SR, Kolitz JE, Cooper M, Yeager AM, Louie AC, Feldman EJ. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood. 2014 May 22;123(21):3239-46. doi: 10.1182/blood-2013-12-540971. Epub 2014 Mar 31.
PMID: 24687088DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Trial Disclosure & Transparency
- Organization
- Jazz Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey E Lancet, MD
H. Lee Moffitt Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 11, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2010
Study Completion
December 1, 2011
Last Updated
January 12, 2018
Results First Posted
January 12, 2018
Record last verified: 2017-10