Clinical trial · Interventional
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.
NCT00389428CI-TRIAL-00006942completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, serious adverse effects and how the body handles CPX-351. Preliminary evidence of antitumor activity will also be determined.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPX-351 (Cytarabine:Daunorubicin) Liposome Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) for use in phase 2
Secondary outcomes (3)
- measure
- To evaluate the safety and dose-limiting toxicities (DLT) of CPX-351.
- measure
- To determine the pharmacokinetic parameters of CPX-351 administered in this schedule.
- measure
- To assess preliminary efficacy information of CPX-351 administered in this schedule in patients with advanced leukemias.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDFeldman EJ, Kolitz JE, Trang JM, Liboiron BD, Swenson CE, Chiarella MT, Mayer LD, Louie AC, Lancet JE. Pharmacokinetics of CPX-351; a nano-scale liposomal fixed molar ratio formulation of cytarabine:daunorubicin, in patients with advanced leukemia. Leuk Res. 2012 Oct;36(10):1283-9. doi: 10.1016/j.leukres.2012.07.006. Epub 2012 Jul 26. PMID 22840315