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

Phase 2

Completed

• Conditions: Leukemia, Lymphoblastic, Acute

• Registration Number: NCT00475280
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief 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

Study Timeline

• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Study Start: 2007-11
• Primary Completion: 2016-12
• Study Completion: 2020-01-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (31)

U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani; 🇮🇹 Salerno, Italy

Nuovo Ospedale "Torrete"; 🇮🇹 Ancona, Italy

USL 8 - Ospedale S.Donato; 🇮🇹 Arezzo, Italy

Az. Ospedaliera S. G. Moscati; 🇮🇹 Avellino, Italy

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

Ospedale Ferrarotto; 🇮🇹 Catania, Italy

Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia; 🇮🇹 Catanzaro, Italy

Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile; 🇮🇹 Civitanova Marche, Italy

Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi; 🇮🇹 Ferrara, Italy

Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"; 🇮🇹 Genova, Italy

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