"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients (LAL1104)
This study is currently recruiting participants.
Verified by Gruppo Italiano Malattie EMatologiche dell'Adulto May 2007
Sponsored by: |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
Information provided by: |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
ClinicalTrials.gov Identifier: |
NCT00475280 |
|
Purpose
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.
Condition |
Intervention |
Phase |
Leukemia, Lymphoblastic, Acute |
Procedure: Geriatric assessment adapted therapy
Procedure: Stem cells autotransplantation |
Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Number of arms in study: 3
Official Title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
Primary Outcome Measures:
- Overall survival in Ph negative ALL patients stratified according to a geriatric assessment [Time Frame: at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients]
Secondary Outcome Measures:
- Complete Response rate [Time Frame: After induction therapy]
- Stem cell autotransplant feasibility [Time Frame: At 6 months from diagnosis]
- Incidence of adult ALL [Time Frame: At diagnosis]
- Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 [Time Frame: At diagnosis and during follow-up]
- Disease free survival [Time Frame: During follow-up]
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Total Enrollment: 102
Study start: May 2007
Treatment:
- Frail patients:
- Pretreatment with PDN
- Induction with Vinblastine and PDN
- Maintenance with MTX, 6-MP, VBL and PDN
- 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
- 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