Acute Myeloid Leukemia MedDRA version: 6.1 Level: HLT Classification code 10024291
Conditions
Interventions
Trade Name: VELCADE
Pharmaceutical Form: Powder for solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Product Name: Zarnestra
Product Cod
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects must fulfill all of the following criteria 1. Provision of written informed consent 2. Male or female aged 18 years with newly diagnosed Acute Myeloid Leukemia AML , de novo or secondary, unfit for conventional chemotherapy 3. Male or female with Acute Myeloid Leukemia in first relapse 60 years 4. WHO performance status 2, or/and unwillingness to receive conventional chemotherapy 5. Negative pregnancy test or evidence of post-menopausal status for female patients. For inclusion in this genetic research, subjects must fulfill the following criterion 1. Provision of informed consent for genetic research. 2. If a subject declines to participate in the genetic research, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Any of the following is regarded as a criterion for exclusion from the study 1. Serum bilirubin 2 x Upper Limit of Normal ULN 2. Aspartate aminotransferase AST/SGOT or alanine aminotransferase ALT/SGPT 3.5 x ULN 3. Serum creatinine 2.5 x ULN or 24-hour creatinine clearance 60 mL/min measured or calculated by Cockcroft-Gault 4. Patients with AML of FAB M3 classification APL 5. Patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission 6. Any clinically defined central nervous system AML. 7. Participation in an investigational drug study within the 30 days prior to entry 8. Evidence of uncontrolled infection or CNS-Hemorragic 9. Patients with documented cases of human immunodeficiency virus HIV 10. Peripheral Neuropathy or Neuropathic Pain grade 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A The primary objective is to assess the safety and tolerability of combinatory use of Zarnestra plus multiple ascending doses of Velcade in patients with newly diagnosed Acute Myeloid Leukemia AML unfit for conventional chemotherapy 18 years or in patients with Acute Myeloid Leukemia in first or subsequent relapse 60 years . Part B The primary objective is to assess the effect of Tipifarnib Zarnestra or R115777 plus the defined in part A dose of Velcade Bortezomib or PS341 in the Treatment of Newly Diagnosed Acute Myeloid Leukemia AML unfit for conventional chemotherapy age 18 years or in Patients in first or subsequent relapse 60 years .;Secondary Objective: Parts A B The secondary objectives are To investigate the effect of Velcade on the expression of NFkB, and biomarkers of NFkB including phosphorylation of c-Rel on leukaemic blasts by flow cytometry, protein analysis, immuno istochemistry, and/or mRNA profiling. Part B only The secondary objectives are To further assess the safety and tolerability of multiple doses of Tipifarnib and Velcade in patients with AML;Primary end point(s): The primary outcome variables are Part A adverse events, vital signs, ECG parameters, clinical chemistry, haematology and urinalysis | — |
Countries
Italy
Outcome results
None listed