Status:
COMPLETED
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to determine the recommended dose of CPX-351 for use in a phase 2 efficacy study in patients with leukemia. Secondarily, the study will assess the safety, seriou...
Detailed Description
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio. The development o...
Eligibility Criteria
Inclusion
- Ability to understand and voluntarily sign an informed consent form
- Age \> 18 years at the time of signing the informed consent form
- Pathological confirmation of leukemia or myelodysplastic syndrome.
- AML according to WHO criteria; except for core-binding factor AMLs (t(8;21), inv(16) or t(16;16)) and APL
- ALL
- MDS
- Patients with AML include the following:
- Patients in 2nd or greater relapse
- Patients in first relapse with initial CR duration lasting \<6 months
- Patients in first relapse refractory to induction therapy
- Patients with primary refractory AML
- Patients with ALL include the following
- Patients with T-cell ALL refractory or in relapse following nelarabine
- Patients with other ALL that is refractory or in relapse.
- Patients with MDS include the following:
- The subset of RAEB-2 patients with \>10% blasts with at least 1 prior therapy that includes a hypomethylating agent.
- Previously untreated chemotherapy induced AML
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2
- Able to adhere to the study visit schedule and other protocol requirements
- Life expectancy of at least 12 weeks
- Laboratory values fulfilling the following:
- Serum creatinine \< 1.5 mg/dL
- Serum total bilirubin \< 1.5 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 MUGA scan or echocardiography
- All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.
Exclusion
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent form
- Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry
- Clinical evidence of active CNS leukemic involvement
- Pregnant or lactating women
- Clinically significant cardiac disease (New York Heart Association Class III or IV)
- Severe debilitating pulmonary disease
- Active and uncontrolled infection. Patients with an infection under active treatment with antibiotics and whose infection is controlled may be entered into the study
- Current evidence of invasive fungal infection (blood or tissue culture); HIV or hepatitis C infection
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-related disorder
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00389428
Start Date
September 1 2006
End Date
December 1 2009
Last Update
May 17 2012
Active Locations (4)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
H. Lee Moffit Cancer Center & Research Institute at the University of S. Florida
Tampa, Florida, United States, 33612-9497
3
North Shore University Hospital
Manhasset, New York, United States, 11030
4
New York Presbyterian Hospital Weill Medical College of Cornell University
New York, New York, United States, 10021