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NCT00475280 Clinical Trial

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

Leukemia, Lymphoblastic, Acute Clinical Trial

— LAL1104  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00475280
Other study ID # LAL1104
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2007
Est. completion date January 28, 2020

Study information
Verified date October 2022
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 102
Est. completion date January 28, 2020
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Geriatric assessment adapted therapy
Geriatric assessment is performed before the induction phase starts.
• Stem cells autotransplantation
Stem cells autotransplantation is performed after consolidation treatment

Locations
Country Name City State
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 U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani Pagani (sa)
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

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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. — View Citation

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, Fière 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. — View Citation

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. — View Citation

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. — View Citation

Sandler DP, Ross JA. Epidemiology of acute leukemia in children and adults. Semin Oncol. 1997 Feb;24(1):3-16. Review. — View Citation

Späth-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. — View Citation

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. — View Citation

Taylor PR, Reid MM, Proctor SJ. Acute lymphoblastic leukaemia in the elderly. Leuk Lymphoma. 1994 May;13(5-6):373-80. Review. — View Citation

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