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

Primary Purpose

Leukemia, Lymphoblastic, Acute

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Geriatric assessment adapted therapy
Stem cells autotransplantation
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphoblastic, Acute focused on measuring geriatric assessment adapted therapy, Leukemia, Lymphoblastic, Acute, Older patients, > 60 years old, Ph negative

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
  • Nuovo Ospedale "Torrete"
  • USL 8 - Ospedale S.Donato
  • Az. Ospedaliera S. G. Moscati
  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
  • Ospedale Ferrarotto
  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
  • Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
  • Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
  • Centro Oncologico Modenese - Dipartimento di Oncoematologia
  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
  • Azienda Ospedaliera Universitaria - Università Federico II
  • Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
  • La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
  • Cattedra di Ematologia CTMO Università degli Studi di Parma
  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
  • UO di Ematologia Centro Oncologico Basilicata
  • Complesso Ospedaliero S. Giovanni Addolorata
  • Divisione Ematologia - Università Campus Bio-Medico
  • Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
  • U.O.C. Ematologia - Ospedale S.Eugenio
  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
  • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
  • Clinica Ematologica - Policlinico Universitario
  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Geriatric assessment

Arm Description

Outcomes

Primary Outcome Measures

Overall survival in Ph negative ALL patients stratified according to a geriatric assessment

Secondary Outcome Measures

Complete Response rate
Stem cell autotransplant feasibility
Incidence of adult ALL
Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60
Disease free survival

Full Information

First Posted
May 17, 2007
Last Updated
October 10, 2022
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT00475280
Brief Title
"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients
Acronym
LAL1104
Official Title
"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2007 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Treatment: Frail patients: Pretreatment with PDN Induction with Vinblastine and PDN Maintenance with MTX, 6-MP, VBL and PDN 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoblastic, Acute
Keywords
geriatric assessment adapted therapy, Leukemia, Lymphoblastic, Acute, Older patients, > 60 years old, Ph negative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Geriatric assessment
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Geriatric assessment adapted therapy
Intervention Description
Geriatric assessment is performed before the induction phase starts.
Intervention Type
Procedure
Intervention Name(s)
Stem cells autotransplantation
Intervention Description
Stem cells autotransplantation is performed after consolidation treatment
Primary Outcome Measure Information:
Title
Overall survival in Ph negative ALL patients stratified according to a geriatric assessment
Time Frame
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 Measure Information:
Title
Complete Response rate
Time Frame
After induction therapy
Title
Stem cell autotransplant feasibility
Time Frame
At 6 months from diagnosis
Title
Incidence of adult ALL
Time Frame
At diagnosis
Title
Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60
Time Frame
At diagnosis and during follow-up
Title
Disease free survival
Time Frame
During follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicetto FERRARA, Dr.
Organizational Affiliation
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
City
Pagani
State/Province
(sa)
Country
Italy
Facility Name
Nuovo Ospedale "Torrete"
City
Ancona
Country
Italy
Facility Name
USL 8 - Ospedale S.Donato
City
Arezzo
Country
Italy
Facility Name
Az. Ospedaliera S. G. Moscati
City
Avellino
Country
Italy
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Ospedale Ferrarotto
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
City
Catanzaro
Country
Italy
Facility Name
Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
City
Civitanova Marche
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
City
Ferrara
Country
Italy
Facility Name
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
City
Genova
Country
Italy
Facility Name
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
City
Lecce
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
City
Messina
Country
Italy
Facility Name
Centro Oncologico Modenese - Dipartimento di Oncoematologia
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Università Federico II
City
Napoli
Country
Italy
Facility Name
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
City
Nocera Inferiore
Country
Italy
Facility Name
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
City
Orbassano
Country
Italy
Facility Name
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
City
Palermo
Country
Italy
Facility Name
Cattedra di Ematologia CTMO Università degli Studi di Parma
City
Parma
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
UO di Ematologia Centro Oncologico Basilicata
City
Rionero in Vulture
Country
Italy
Facility Name
Complesso Ospedaliero S. Giovanni Addolorata
City
Roma
Country
Italy
Facility Name
Divisione Ematologia - Università Campus Bio-Medico
City
Roma
Country
Italy
Facility Name
Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
City
Roma
Country
Italy
Facility Name
U.O.C. Ematologia - Ospedale S.Eugenio
City
Roma
Country
Italy
Facility Name
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
City
Roma
Country
Italy
Facility Name
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
City
Salerno
Country
Italy
Facility Name
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
City
Sassari
Country
Italy
Facility Name
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
City
Siena
Country
Italy
Facility Name
Clinica Ematologica - Policlinico Universitario
City
Udine
Country
Italy
Facility Name
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
City
Verona
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9045302
Citation
Sandler DP, Ross JA. Epidemiology of acute leukemia in children and adults. Semin Oncol. 1997 Feb;24(1):3-16.
Results Reference
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PubMed Identifier
1382705
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.
Results Reference
background
PubMed Identifier
8069181
Citation
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.
Results Reference
background
PubMed Identifier
7803263
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. doi: 10.1111/j.1365-2141.1994.tb04982.x.
Results Reference
background
PubMed Identifier
2209825
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. doi: 10.1111/j.1600-0609.1990.tb00424.x.
Results Reference
background
PubMed Identifier
7993936
Citation
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.
Results Reference
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PubMed Identifier
7564503
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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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, 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.
Results Reference
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PubMed Identifier
34048072
Citation
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.
Results Reference
derived
Links:
URL
http://www.gimema.it
Description
GIMEMA's Web page

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

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