Geriatric Assessment Adapted Therapy for Ph- ALL Elderly Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Leukemia, Lymphoblastic, Acute

Intervention / Treatment
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* Procedure: Geriatric assessment adapted therapy
* Procedure: Stem cells autotransplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Geriatric assessment<br> | Procedure: Geriatric assessment adapted therapy<br>* Geriatric assessment is performed before the induction phase starts.<br>Procedure: Stem cells autotransplantation<br>* Stem cells autotransplantation is performed after consolidation treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in Ph negative ALL patients stratified according to a geriatric assessment |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response rate |  | After induction therapy | 
| Stem cell autotransplant feasibility |  | At 6 months from diagnosis | 
| Incidence of adult ALL |  | At diagnosis | 
| Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 |  | At diagnosis and during follow-up | 
| Disease free survival |  | During follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older patients, geriatric assessment adapted therapy, Leukemia, Lymphoblastic, Acute, > 60 years old, Ph negative