Clinical trial NCT00475280: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients
Official title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphoblastic, Acute
Keywords: geriatric assessment adapted therapy
Leukemia, Lymphoblastic, Acute
Older patients
> 60 years old
Ph negative
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2007-05-21
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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

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

Primary outcomes:
measure: Overall survival in Ph negative ALL patients stratified according to a geriatric assessment
timeFrame: 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:
measure: Complete Response rate
timeFrame: After induction therapy
measure: Stem cell autotransplant feasibility
timeFrame: At 6 months from diagnosis
measure: Incidence of adult ALL
timeFrame: At diagnosis
measure: Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60
timeFrame: At diagnosis and during follow-up
measure: Disease free survival
timeFrame: During follow-up
Other outcomes:
Locations:
city: Pagani
country: Italy
facility: U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
state: (sa)
city: Ancona
country: Italy
facility: Nuovo Ospedale "Torrete"
city: Arezzo
country: Italy
facility: USL 8 - Ospedale S.Donato
city: Avellino
country: Italy
facility: Az. Ospedaliera S. G. Moscati
city: Bologna
country: Italy
facility: Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
city: Civitanova Marche
country: Italy
facility: Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
city: Genova
country: Italy
facility: Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
city: Lecce
country: Italy
facility: ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
city: Modena
country: Italy
facility: Centro Oncologico Modenese - Dipartimento di Oncoematologia
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Università Federico II
city: Nocera Inferiore
country: Italy
facility: Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
city: Orbassano
country: Italy
facility: Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
city: Palermo
country: Italy
facility: La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
city: Parma
country: Italy
facility: Cattedra di Ematologia CTMO Università degli Studi di Parma
city: Reggio Calabria
country: Italy
facility: Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
city: Rionero in Vulture
country: Italy
facility: UO di Ematologia Centro Oncologico Basilicata
city: Roma
country: Italy
facility: Complesso Ospedaliero S. Giovanni Addolorata
city: Roma
country: Italy
facility: Divisione Ematologia - Università Campus Bio-Medico
city: Roma
country: Italy
facility: Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: U.O.C. Ematologia - Ospedale S.Eugenio
city: Roma
country: Italy
facility: Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
city: Salerno
country: Italy
facility: U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
city: San Giovanni Rotondo
country: Italy
facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
city: Siena
country: Italy
facility: U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
city: Udine
country: Italy
facility: Clinica Ematologica - Policlinico Universitario
city: Verona
country: Italy
facility: Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Study officials:
affiliation: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
name: Felicetto FERRARA, Dr.
role: PRINCIPAL_INVESTIGATOR
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