Temozolomide in the chemo-immuno-therapy of refractory acute leukaemia of adult patients: The TRIAC protocol - TRIAC
- Conditions
- Refractory acute leukaemiaMedDRA version: 9.1Level: LLTClassification code 10000831Term: Acute leukaemia NOS
- Registration Number
- EUCTR2009-009938-33-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method