Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

Acute Myeloid Leukemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788892
• Other study ID #: CLTR0308-204
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2008
• Last updated: December 15, 2017
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: October 2017
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CPX-351

• Cytarabine

• Daunorubicin

Locations

Country	Name	City	State
Canada	Queen Elisabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	McGill University Department of Oncology	Montreal	Quebec
Canada	BC Cancer Research Center	Vancouver	British Columbia
United States	Blood and Marrow Transplant Group of Georgia	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	St.Francis Hospital	Beech Grove	Indiana
United States	Blumenthal Cancer Center/Mecklenburg Medical Group	Charlotte	North Carolina
United States	Robert H.Lurie Comprehensive Cancer Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Jewish Hospital	Cincinnati	Ohio
United States	Northern New Jersey Cancer Associates	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	Shands Jacksonville Medical Center	Jacksonville	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Joe Arrington Cancer Center	Lubbock	Texas
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	North Shore University Hospital	Manhasset	New York
United States	Froedlert Hospital/Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Weil Cornell Medical Center	New York	New York
United States	University of Pittsburg Cancer Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	UC Davis Cancer Center	Sacramento	California
United States	Cancer Therapy and Research Center at the University of Texas	San Antonio	Texas
United States	University of California Medical Center	San Francisco	California
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Arizona Cancer Center	Tucson	Arizona
United States	New York Medical College, Division of Oncology	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Remission Duration/Time to Remission	Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.; Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met.	Following achievement of CR over the study period
Secondary	Event Free Survival	Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.	Up to 1 year from randomization
Secondary	Overall Survival Rate at 1 Year	Survival defined as the time from randomization to death.	1 year
Secondary	Rate of Stem Cell Transplant	The rate of patients who underwent stem cell transplant.	Up to 1 year
Secondary	Aplasia Rate	Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.	Day 14 (1st Induction)