LAL1104: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00475280
• Collaborator: (none)
• Enrollment: 102
• Locations: 32
• Arm: 1
• Anticipated Duration (Months): 131
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphoblastic, Acute	Procedure: Geriatric assessment adapted therapy; Procedure: Stem cells autotransplantation	Phase 2

Detailed Description

Treatment:

1. Frail patients:

• Pretreatment with PDN

• Induction with Vinblastine and PDN

• Maintenance with MTX, 6-MP, VBL and PDN

1. 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

1. 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 102 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
• Actual Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Geriatric assessment	Procedure: Geriatric assessment adapted therapy; Geriatric assessment is performed before the induction phase starts.; Procedure: Stem cells autotransplantation; Stem cells autotransplantation is performed after consolidation treatment

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Complete Response rate [After induction therapy]

2. Stem cell autotransplant feasibility [At 6 months from diagnosis]

3. Incidence of adult ALL [At diagnosis]

4. Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 [At diagnosis and during follow-up]

5. Disease free survival [During follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani	Pagani	(sa)	Italy
2	Nuovo Ospedale "Torrete"	Ancona		Italy
3	USL 8 - Ospedale S.Donato	Arezzo		Italy
4	Az. Ospedaliera S. G. Moscati	Avellino		Italy
5	Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi	Bologna		Italy
6	Ospedale Ferrarotto	Catania		Italy
7	Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia	Catanzaro		Italy
8	Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile	Civitanova Marche		Italy
9	Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi	Ferrara		Italy
10	Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"	Genova		Italy
11	ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE	Lecce		Italy
12	Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina	Messina		Italy
13	Centro Oncologico Modenese - Dipartimento di Oncoematologia	Modena		Italy
14	Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"	Napoli		Italy
15	Azienda Ospedaliera Universitaria - Università Federico II	Napoli		Italy
16	Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I	Nocera Inferiore		Italy
17	Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga	Orbassano		Italy
18	La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello	Palermo		Italy
19	Cattedra di Ematologia CTMO Università degli Studi di Parma	Parma		Italy
20	Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"	Reggio Calabria		Italy
21	UO di Ematologia Centro Oncologico Basilicata	Rionero in Vulture		Italy
22	Complesso Ospedaliero S. Giovanni Addolorata	Roma		Italy
23	Divisione Ematologia - Università Campus Bio-Medico	Roma		Italy
24	Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena	Roma		Italy
25	U.O.C. Ematologia - Ospedale S.Eugenio	Roma		Italy
26	Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia	Roma		Italy
27	U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani	Salerno		Italy
28	Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo		Italy
29	Serv. di Ematologia Ist. di Ematologia ed Endocrinologia	Sassari		Italy
30	U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"	Siena		Italy
31	Clinica Ematologica - Policlinico Universitario	Udine		Italy
32	Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi	Verona		Italy

Sponsors and Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

• Principal Investigator: Felicetto FERRARA, Dr., Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
• ClinicalTrials.gov Identifier: NCT00475280
• Other Study ID Numbers: LAL1104
• First Posted: May 21, 2007
• Last Update Posted: Aug 6, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto: geriatric assessment adapted therapy; Leukemia, Lymphoblastic, Acute; Older patients; > 60 years old; Ph negative
• Additional relevant MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Aug 6, 2018