"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients
NCT ID: NCT00475280
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2007-11-30
2020-01-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Geriatric assessment
Geriatric assessment adapted therapy
Geriatric assessment is performed before the induction phase starts.
Stem cells autotransplantation
Stem cells autotransplantation is performed after consolidation treatment
Interventions
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Geriatric assessment adapted therapy
Geriatric assessment is performed before the induction phase starts.
Stem cells autotransplantation
Stem cells autotransplantation is performed after consolidation treatment
Eligibility Criteria
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Inclusion Criteria
* Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
* Signed informed consent
Exclusion Criteria
* Ph+ ALL
* Refuse to sign informed consent
60 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Felicetto FERRARA, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
Locations
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U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
Pagani, (SA), 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
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"
Napoli, , Italy
Azienda Ospedaliera Universitaria - Università Federico II
Napoli, , 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
Countries
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References
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Sandler DP, Ross JA. Epidemiology of acute leukemia in children and adults. Semin Oncol. 1997 Feb;24(1):3-16.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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GIMEMA's Web page
Other Identifiers
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LAL1104
Identifier Type: -
Identifier Source: org_study_id
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