MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate
NCT ID: NCT02067143
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2014-05-20
2020-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study population
In this phase II multicentric trial, eligible patients with Ph- ALL/LL will receive homogeneous supportive care and chemotherapy and will be homogeneously analyzed for response at prefixed timepoints from induction day 1. For risk-/MRD-oriented therapy, CR patients will be stratified by risk class according to diagnostic characteristics, MRD study and CT/PET (LL only) results during early consolidation.
Prephase PDN + CY
Cycle 1 Induction
Cycle 2 Induction / Early consolidation
Cycle 3 Early consolidation
Cycle 4 Consolidation
Cycle 5 Consolidation
Cycle 6 Consolidation
Cycle 7 Consolidation
Cycle 8 Reinduction
Maintenance
If MRD negative MRD u/k SR
Allogeneic SCT or Autologous SCT
If MRD positive MRD u/k HR
Interventions
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Prephase PDN + CY
Cycle 1 Induction
Cycle 2 Induction / Early consolidation
Cycle 3 Early consolidation
Cycle 4 Consolidation
Cycle 5 Consolidation
Cycle 6 Consolidation
Cycle 7 Consolidation
Cycle 8 Reinduction
Maintenance
If MRD negative MRD u/k SR
Allogeneic SCT or Autologous SCT
If MRD positive MRD u/k HR
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years.
* A diagnosis of untreated Ph- ALL or LL is required, either de novo or secondary to chemo-radiotherapy for other cancer. Pretreatment with low-dose corticosteroids in patients presenting with hyperleukocytosis is allowed. All diagnostic procedures need to be performed on freshly obtained bone marrow (BM) and peripheral blood (PB) samples. The diagnosis must be one of: de novo ALL, secondary ALL, B-/T-cell LL Full cytological, cytochemical, cytogenetic and immunobiological disease characterization according to EGIL and WHO classifications. Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) are required for MRD study. Detailed indications on patient registration, storage of representative diagnostic material and diagnostic work-up, including the forwarding of samples for MRD study are given in Appendix B.
* Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study.
* ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by preexisting comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures.
Exclusion Criteria
* Down's syndrome
* Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), severe liver disease with serum bilirubin \>3 mg/dL and/or ALT \>3 x upper normal limit (unless attributable to ALL), kidney function impairment with serum creatinine \>2 mg/dL (unless attributable to ALL), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan. N.B. For altered liver and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
* Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is sent off study.
* A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with life expectancy \<1 year.
* Pregnancy declared by the patient herself, unless a decision is taken with the patient to induce a therapeutic abortion in order to carry on with ALL therapy. A pregnancy test is performed at diagnosis but does not preclude the enrolment into study. Fertile patients will be advised to adopt contraceptive methods while on treatment.
18 Years
65 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Renato Bassan, Pr.
Role: STUDY_CHAIR
Azienda ULSS 12 Veneziana
Roberto Foà, Pr.
Role: STUDY_DIRECTOR
Policlinico Umberto I, Hematology Department.
Locations
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S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Ancona, , Italy
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno, , Italy
Az.Ospedaliera S.G.Moscati
Avellino, , Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, , Italy
Azienda Ospedaliera - Papa Giovanni XXIII
Bergamo, , Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, , Italy
Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio
Bolzano, , Italy
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
Brescia, , Italy
Divisione di Ematologia Ospedale A. Perrino
Brindisi, , Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, , Italy
CTMO - Ematologia - Ospedale "Binaghi"
Cagliari, , Italy
Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
Caserta, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, , Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Cona, , Italy
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
Cremona, , Italy
S.C. Ematologia ASO S. Croce e Carle
Cuneo, , Italy
IRCCS_AOU San Martino-IST.Clinica Ematologica
Genova, , Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, , Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo
Messina, , Italy
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Mestre, , Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, , Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan, , Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milan, , Italy
UO Ematologia - AOU Policlinico di Modena
Modena, , Italy
Azienda Ospedaliera "S.Gerardo"
Monza, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, , Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, , Italy
U.O. CTMO Ematologia - Osp. S.Francesco
Nuoro, , Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano, , Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padua, , Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, , Italy
U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone"
Palermo, , Italy
Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Palermo - Uo Oncoematologia E Tmo
Palmero, , Italy
Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1 TORRE DELLE MEDICINE, 6° piano
Parma, , Italy
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
Perugia, , Italy
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro, , Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, , Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza, , Italy
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa, , Italy
Ematologia - Ospedale San Carlo
Potenza, , Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, , Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, , Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Ospedale "Infermi"
Rimini, , Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, , Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, , Italy
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
Sezione di Ematologia Cancer Center Humanitas
Rozzano, , Italy
UOC di Ematologia e Trapianti di Cellule Staminali Emopoietiche - AOU San Giovanni di Dio e Ruggi D'Aragona
Salerno, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, , Italy
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino, , Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino, , Italy
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
Torino, , Italy
U.L.S.S. 9 UOC Ematologia - Ospedale Ca' Foncello
Treviso, , Italy
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
Udine, , Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, , Italy
Countries
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References
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Bassan R, Chiaretti S, Della Starza I, Spinelli O, Santoro A, Paoloni F, Messina M, Elia L, De Propris MS, Scattolin AM, Audisio E, Marbello L, Borlenghi E, Zappasodi P, Mauro E, Martinelli G, Mattei D, Fracchiolla N, Bocchia M, De Fabritiis P, Bonifacio M, Candoni A, Cassibba V, Di Bartolomeo P, Latte G, Trappolini S, Guarini A, Vitale A, Fazi P, Piciocchi A, Rambaldi A, Foa R. Pegaspargase-modified risk-oriented program for adult acute lymphoblastic leukemia: results of the GIMEMA LAL1913 trial. Blood Adv. 2023 Aug 22;7(16):4448-4461. doi: 10.1182/bloodadvances.2022009596.
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.
Related Links
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GIMEMA Foundation
Other Identifiers
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LAL1913
Identifier Type: -
Identifier Source: org_study_id
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