"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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Leukemia, Lymphoblastic, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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

External Links

•   GIMEMA's Web page