''Geriatric assessment adapted'' therapy for the treatment of Ph-negative Acute lymphoblastic Leukemia in elder patients. - GIMEMA LAL 1104
- Conditions
- Acute lymphoblastic leukemia Ph- of the elderMedDRA version: 14.1Level: PTClassification code 10000846Term: Acute lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-002156-17-IT
- Lead Sponsor
- G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
age> 60 years Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
Age <= 60 years ALL Ph+
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Overall survival in Ph-negative Acute lymphoblastic Leukemia patients stratified by ''Geriatric assessment adapted'' therapy.;Secondary Objective: RC rate Feasibility of PBSC autotransplantation ALL incidence in elder patients Molecular, cytogenetic and immunophenotypic heterogeneity evaluation in Ph-negative Acute lymphoblastic Leukemia patients >60 years old Disease free survival;Primary end point(s): Overall survival in Ph-negative Acute lymphoblastic Leukemia patients stratified for ''Geriatric assessment adapted'' therapy.
- Secondary Outcome Measures
Name Time Method