Acute lymphoblastic leukemia Ph- of the elder MedDRA version: 14.1 Level: PT Classification code 10000846 Term: Acute lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: DELTACORTENE*10CPR 5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
Concentration unit: mg milligram(s)
Concentration number: 5-
Trade Name: DELTACORTENE FORTE*10CPR 25MG
P
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Age <= 60 years ALL Ph+
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed