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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.
Treatment:
Frail patients:
Fit patients:
Intermediate patients:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric assessment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric assessment adapted therapy | Procedure | Geriatric assessment is performed before the induction phase starts. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response rate | After induction therapy | |
| Stem cell autotransplant feasibility | At 6 months from diagnosis | |
| Incidence of adult ALL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felicetto FERRARA, Dr. | Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani | Pagani | (SA) | Italy | |||
| Nuovo Ospedale "Torrete" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9045302 | Background | Sandler DP, Ross JA. Epidemiology of acute leukemia in children and adults. Semin Oncol. 1997 Feb;24(1):3-16. | |
| 1382705 | Background | Taylor PR, Reid MM, Bown N, Hamilton PJ, Proctor SJ. Acute lymphoblastic leukemia in patients aged 60 years and over: a population-based study of incidence and outcome. Blood. 1992 Oct 1;80(7):1813-7. |
| Label | URL |
|---|---|
| GIMEMA's Web page | View source |
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| Stem cells autotransplantation | Procedure | Stem cells autotransplantation is performed after consolidation treatment |
|
| 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 |
| 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 |
| 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 |
| Centro Oncologico Modenese - Dipartimento di Oncoematologia | Modena | Italy |
| Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" | Naples | Italy |
| Azienda Ospedaliera Universitaria - Università Federico II | Naples | Italy |
| Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I | Nocera Inferiore | 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 |
| Cattedra di Ematologia CTMO Università degli Studi di Parma | Parma | Italy |
| Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" | Reggio Calabria | Italy |
| UO di Ematologia Centro Oncologico Basilicata | Rionero in Vulture | Italy |
| Complesso Ospedaliero S. Giovanni Addolorata | Roma | 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 |
| U.O.C. Ematologia - Ospedale S.Eugenio | Roma | Italy |
| Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia | Roma | Italy |
| U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani | Salerno | Italy |
| Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | 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 |
| 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 |
| 8069181 | Background | Taylor PR, Reid MM, Proctor SJ. Acute lymphoblastic leukaemia in the elderly. Leuk Lymphoma. 1994 May;13(5-6):373-80. doi: 10.3109/10428199409049625. |
| 7803263 | Background | Kantarjian HM, O'Brien S, Smith T, Estey EH, Beran M, Preti A, Pierce S, Keating MJ. Acute lymphocytic leukaemia in the elderly: characteristics and outcome with the vincristine-adriamycin-dexamethasone (VAD) regimen. Br J Haematol. 1994 Sep;88(1):94-100. doi: 10.1111/j.1365-2141.1994.tb04982.x. |
| 2209825 | Background | Delannoy A, Ferrant A, Bosly A, Chatelain C, Doyen C, Martiat P, Michaux JL, Sokal G. Acute lymphoblastic leukemia in the elderly. Eur J Haematol. 1990 Aug;45(2):90-3. doi: 10.1111/j.1600-0609.1990.tb00424.x. |
| 7993936 | Background | Spath-Schwalbe E, Heil G, Heimpel H. Acute lymphoblastic leukemia in patients over 59 years of age. Experience in a single center over a 10-year period. Ann Hematol. 1994 Dec;69(6):291-6. doi: 10.1007/BF01696557. |
| 7564503 | Background | Ferrari A, Annino L, Crescenzi S, Romani C, Mandelli F. Acute lymphoblastic leukemia in the elderly: results of two different treatment approaches in 49 patients during a 25-year period. Leukemia. 1995 Oct;9(10):1643-7. |
| 8819079 | Background | Bassan R, Di Bona E, Lerede T, Pogliani E, Rossi G, D'Emilio A, Buelli M, Rambaldi A, Viero P, Rodeghiero F, Barbui T. Age-adapted moderate-dose induction and flexible outpatient postremission therapy for elderly patients with acute lymphoblastic leukemia. Leuk Lymphoma. 1996 Jul;22(3-4):295-301. doi: 10.3109/10428199609051761. |
| 9305593 | Background | Delannoy A, Sebban C, Cony-Makhoul P, Cazin B, Cordonnier C, Bouabdallah R, Cahn JY, Dreyfus F, Sadoun A, Vernant JP, Gay C, Broustet A, Michaux JL, Fiere D. Age-adapted induction treatment of acute lymphoblastic leukemia in the elderly and assessment of maintenance with interferon combined with chemotherapy. A multicentric prospective study in forty patients. French Group for Treatment of Adult Acute Lymphoblastic Leukemia. Leukemia. 1997 Sep;11(9):1429-34. doi: 10.1038/sj.leu.2400780. |
| 34048072 | Derived | Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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