Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study versus Allopurinol - FLORENCE

Menarini Ricerche S.p.A.0 个研究点目标入组 340 人开始时间: 2012年8月13日最近更新: 2013年11月11日

试验速览

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•1.Male or female patients
•a. aged = 18 years, and
•b. scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies, and
•c. at intermediate or high risk of TLS (see Appendix II, section 13.2 of study protocol for risk stratification), and
•d. with sUA levels < 10 mg/dL at randomization (Visit 1), and
•e. candidate to Allopurinol treatment or have no access to Rasburicase.
•2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
•3. Female of childbearing potential may be enrolled providing a negative pregnancy test at screening and using a highly effective method of birth control resulting in a low failure rate (i.e. less than 1% per year).
•4. Able to give written informed consent before any study related procedure.
•5. Able to attend all the visits scheduled in the study.
•6. Life expectancy > 1 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 240
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1. Patients known to be hypersensitive to Febuxostat or Allopurinol or to any of the components of the formulations.
•2. Patients with hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactase malabsorption.
•3. Patients with uncontrolled ischemic heart disease or congestive heart failure (CHF).
•4. Pregnant or breast feeding women.
•5. Patients with sUA levels = 10 mg/dL at randomization (Visit 1).
•6. Patients receiving Febuxostat, Allopurinol or any other urate lowering therapy (e.g. Rasburicase, probenecid) within 30 days prior to randomization.
•7. Patients receiving mercaptopurine and azathioprine within 14 days prior to randomization.
•8. High risk patients NOT candidate to Allopurinol treatment.
•9. Patients with severe renal insufficiency.
•10. Patients with severe hepatic insufficiency.
•11. Patients with diagnosis of LTLS or CTLS at randomization (Visit 1).
•12. Patients with any serious concomitant illness which, in the opinion of the Investigator, is incompatible with the protocol.
•13. Patients receiving any other investigational agent within 30 days prior to randomization (Visit 1).

发起方

Menarini Ricerche S.p.A.