Refractory acute leukaemia MedDRA version: 9.1 Level: LLT Classification code 10000831 Term: Acute leukaemia NOS
Conditions
Interventions
Trade Name: TEMODAL*1FL 20CPS 5MG
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Temozolomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Nam
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consent. Age ≥ 18 years Histologically confirmed acute leukaemia Diagnosis of acute refractory leukaemia or patient not eligible for first and second line standard chemotherapy Levels of MGMT associated with leukaemic blasts (obtained from bone marrow or peripheral blood): MGMT:beta-actin ratio (Western Blot analysis) not higher than 0.4 or MGMT activity (enzymatic determination) not exceeding 200 fM/mg protein Effective contraception for both male and female patients if the risk of conception exists. 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: Presence of alteration of: Liver: bilirubin > 3 times the upper limit of normal Kidney: creatinine > 3 times the upper limit of normal Cardiovascular system: Severe heart failure (class 3, 4 NYCG). Pregnant or breast feeding women. Drug habit or alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of TMZ+ IL-2 in improving overall survival of patients with MGMT-deficient leukaemia, refractory to treatment or not eligible to aggressive therapy due to underlying medical conditions.;Secondary Objective: To establish the safety, the short-term response (generally within the first cycle of treatment), and time of disease control.;Primary end point(s): OS E PFS | — |
Countries
Italy
Outcome results
None listed