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

NCT00475280 | Completed Phase 2

• 1 other identifier: LAL1104
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 32

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.

Conditions

Leukemia, Lymphoblastic, Acute

Keywords

geriatric assessment adapted therapy; Leukemia, Lymphoblastic, Acute; Older patients; > 60 years old; Ph negative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Geriatric assessment

OTHER

Procedure: Geriatric assessment adapted therapy; Procedure: Stem cells autotransplantation

Interventions

Geriatric assessment adapted therapy PROCEDURE

Geriatric assessment is performed before the induction phase starts.

Geriatric assessment

Stem cells autotransplantation PROCEDURE

Stem cells autotransplantation is performed after consolidation treatment

Geriatric assessment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<= 60 years old
• Ph+ ALL
• Refuse to sign informed consent

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (32)

U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

Pagani, (SA), Italy

Location

Nuovo Ospedale "Torrete"

Ancona, Italy

Location

USL 8 - Ospedale S.Donato

Arezzo, Italy

Location

Az. Ospedaliera S. G. Moscati

Avellino, Italy

Location

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

Ospedale Ferrarotto

Catania, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

Catanzaro, Italy

Location

Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile

Civitanova Marche, Italy

Location

Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

Ferrara, Italy

Location

Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

Genova, Italy

Location

ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Lecce, Italy

Location

Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

Messina, Italy

Location

Centro Oncologico Modenese - Dipartimento di Oncoematologia

Modena, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

Napoli, Italy

Location

Azienda Ospedaliera Universitaria - Università Federico II

Napoli, Italy

Location

Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I

Nocera Inferiore, Italy

Location

Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga

Orbassano, Italy

Location

La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello

Palermo, Italy

Location

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, Italy

Location

Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

Reggio Calabria, Italy

Location

UO di Ematologia Centro Oncologico Basilicata

Rionero in Vulture, Italy

Location

Complesso Ospedaliero S. Giovanni Addolorata

Roma, Italy

Location

Divisione Ematologia - Università Campus Bio-Medico

Roma, Italy

Location

Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

Roma, Italy

Location

U.O.C. Ematologia - Ospedale S.Eugenio

Roma, Italy

Location

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, Italy

Location

U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

Salerno, Italy

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

Sassari, Italy

Location

U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

Siena, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Verona, Italy

Location

Related Publications (10)

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

  PMID: 9045302 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.

  PMID: 1382705 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.

  PMID: 8069181 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.

  PMID: 7803263 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.

  PMID: 2209825 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.

  PMID: 7993936 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.

  PMID: 7564503 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.

  PMID: 8819079 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.

  PMID: 9305593 BACKGROUND

• 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.

  PMID: 34048072 DERIVED

Related Links

• GIMEMA's Web page

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Felicetto FERRARA, Dr.

  Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: January 28, 2020
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (32)