Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies

Conditions: Tumor Lysis Syndrome
MedDRA version: 14.1Level: PTClassification code 10045170Term: Tumour lysis syndromeSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1Level: LLTClassification code 10045152Term: Tumor lysis syndromeSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-000776-42-DE

Lead Sponsor: Menarini Ricerche S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

Inclusion Criteria

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

Exclusion Criteria

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).