NCT00475280

"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients

"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Leukemia, Lymphoblastic, Acute

Interventions

Type	Name	Description
PROCEDURE	Geriatric assessment adapted therapy	Geriatric assessment is performed before the induction phase starts.
PROCEDURE	Stem cells autotransplantation	Stem cells autotransplantation is performed after consolidation treatment

Timeline

• Start date: 2007-11-01
• Primary completion: 2016-12-01
• Completion: 2020-01-28
• First posted: 2007-05-21
• Last updated: 2022-10-12

Locations

32 sites across 1 country: Italy