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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.


Phase 2
60 Years
75 Years
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Remission Rate

Outcome Time Frame:

Following 1st induction, following 2nd induction if applicable

Safety Issue:

No

Principal Investigator

Jeffrey E Lancet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CLTR0308-204

NCT ID:

NCT00788892

Start Date:

October 2008

Completion Date:

December 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute
  • Myeloid
  • Leukemia
  • elderly
  • Newly
  • Diagnosed
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Colorado Cancer CenterDenver, Colorado  80262
Rush University Medical CenterChicago, Illinois  60612-3824
North Shore University HospitalManhasset, New York  11030
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Joe Arrington Cancer CenterLubbock, Texas  79410
Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia  30342-1601
UC Davis Cancer CenterSacramento, California  95817
Northern New Jersey Cancer AssociatesHackensack, New Jersey  07601
Oregon Health and Science UniversityPortland, Oregon  97201
Jewish HospitalCincinnati, Ohio  45236
Shands Jacksonville Medical CenterJacksonville, Florida  32209
Texas Tech University Health Sciences CenterLubbock, Texas  79430
University of California Medical CenterSan Francisco, California  94143
H Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Robert H.Lurie Comprehensive Cancer CenterChicago, Illinois  60611
St.Francis HospitalBeech Grove, Indiana  46107
Weil Cornell Medical CenterNew York, New York  10021
New York Medical College, Division of OncologyValhalla, New York  10595
Blumenthal Cancer Center/Mecklenburg Medical GroupCharlotte, North Carolina  28204
University of Pittsburg Cancer CenterPittsburg, Pennsylvania  15232
Cancer Therapy and Research Center at the University of TexasSan Antonio, Texas  78229
Froedlert Hospital/Medical College of WisconsinMilwaukee, Wisconsin  53226