"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients (LAL1104)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status and phase: Completed; Phase 2

Conditions: Leukemia, Lymphoblastic, Acute

Treatments: Procedure: Geriatric assessment adapted therapy; Procedure: Stem cells autotransplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00475280

LAL1104

Details and patient eligibility

About

This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.

Full description

Treatment:

1. Frail patients:

   • Pretreatment with PDN
   • Induction with Vinblastine and PDN
   • Maintenance with MTX, 6-MP, VBL and PDN

2. Fit patients:

   • Pretreatment with PDN
   • Induction with VCR, DNR and PDN
   • Consolidation with MTX, ARA-C and G-CSF
   • Autologous transplantation
   • Maintenance with MTX, 6-MP, VCR, and PDN

3. Intermediate patients:

   • Pretreatment with PDN
   • Induction with VCR, DNR and PDN
   • Consolidation with MTX, ARA-C and G-CSF
   • A second cycle of consolidation therapy
   • Maintenance with MTX, 6-MP, VCR, and PDN

Enrollment: 102 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 60 years old
• Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
• Signed informed consent

Exclusion criteria

• Age <= 60 years old
• Ph+ ALL
• Refuse to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Geriatric assessment

Other group

Treatment:

Procedure: Stem cells autotransplantation

Procedure: Geriatric assessment adapted therapy