"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients
- Conditions
- Leukemia, Lymphoblastic, Acute
- Interventions
- Procedure: Geriatric assessment adapted therapyProcedure: Stem cells autotransplantation
- Registration Number
- NCT00475280
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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
- Age <= 60 years old
- Ph+ ALL
- Refuse to sign informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Geriatric assessment Geriatric assessment adapted therapy - Geriatric assessment Stem cells autotransplantation -
- 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)
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
🇮🇹Napoli, Italy
USL 8 - Ospedale S.Donato
🇮🇹Arezzo, Italy
Az. Ospedaliera S. G. Moscati
🇮🇹Avellino, Italy
Nuovo Ospedale "Torrete"
🇮🇹Ancona, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
🇮🇹Catanzaro, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
🇮🇹Genova, Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia
🇮🇹Modena, Italy
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
🇮🇹Salerno, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
🇮🇹Ferrara, Italy
Ospedale Ferrarotto
🇮🇹Catania, Italy
Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
🇮🇹Civitanova Marche, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
🇮🇹Lecce, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
🇮🇹Messina, Italy
Azienda Ospedaliera Universitaria - Università Federico II
🇮🇹Napoli, Italy
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
🇮🇹Nocera Inferiore, Italy
UO di Ematologia Centro Oncologico Basilicata
🇮🇹Rionero in Vulture, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
🇮🇹Parma, Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
🇮🇹Orbassano, Italy
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
🇮🇹Palermo, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
🇮🇹Reggio Calabria, Italy
Divisione Ematologia - Università Campus Bio-Medico
🇮🇹Roma, Italy
Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Complesso Ospedaliero S. Giovanni Addolorata
🇮🇹Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
🇮🇹Roma, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
🇮🇹Roma, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
🇮🇹Sassari, Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
🇮🇹Siena, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Clinica Ematologica - Policlinico Universitario
🇮🇹Udine, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
🇮🇹Verona, Italy