Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia
NCT ID: NCT03367299
Last Updated: 2025-01-22
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
149 participants
INTERVENTIONAL
2018-06-08
2024-09-02
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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Chemotherapy + Blinatumomab
Treatment sequence consists of eight chemotherapy courses and two blinatumomab courses. Patients not in CR after chemotherapy course 2 will go off-study.
Chemotherapy + Blinatumomab
Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.
Interventions
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Chemotherapy + Blinatumomab
Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.
Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years.
* A diagnosis of untreated Ph- CD19+ BCP ALL is required, either de novo or secondary to chemo-radiotherapy for another cancer. Pre-treatment with low-dose corticosteroids in patients presenting with hyperleukocytosis is allowed. Before enrolment and pre-phase is allowed only in patients presenting with severe, potentially life-threatening disease-related clinical symptoms. All diagnostic procedures need to be performed on freshly obtained bone marrow (BM) and peripheral blood (PB) samples.
* Full cytological, cytochemical, immunophenotypic, cytogenetic and molecular disease characterization according to the EGIL and WHO classifications.
* BM and PB sampling for MRD evaluations study. Detailed indications on patient registration, storage of representative diagnostic material and diagnostic work-up, including the shipping of samples for the diagnostic work-up and MRD follow-up studies are given in Appendix A.
* An ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself, (and not by pre-existing comorbidities,) and is considered and/or documented to be reversible following the application of anti-leukemic therapy and appropriate supportive measures.
Exclusion Criteria
* Active CNS leukemia documented by diagnostic lumbar puncture on days -1 to -5 prior to the first blinatumomab administration, or any other clinical sign or symptom ascribable to symptomatic/documented CNS disease at time of each planned blinatumomab course.
* Down's syndrome.
* A 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.
* Presence of serious, active, uncontrolled infections.
* Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
* A history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with a life expectancy \<1 year.
* Pregnancy declared by the patient, unless a decision is taken with the patient to induce a therapeutic abortion in order to carry on with the 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
Role: STUDY_CHAIR
Azienda ULSS 12 "Veneziana" U.O. Ematologia Direttore Renato Bassan
Roberto Foà
Role: STUDY_DIRECTOR
Policlinico Umberto I, Hematology Department.
Alessandro Rambaldi
Role: STUDY_DIRECTOR
Ospedale di Bergamo
Locations
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Clinica Ematologica-Centro Trapianti e Terapie cellulari AOU,
Udine, , Italy
AOU 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
UOC di Ematologia - Istituto Tumori - Giovanni Paolo II
Bari, , Italy
UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
Barletta, , Italy
Azienda Ospedaliera - Papa Giovanni XXIII
Bergamo, , Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - 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
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, , Italy
S.C. Ematologia ASO S. Croce e Carle
Cuneo, , Italy
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio
Florence, , Italy
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
Genova, , Italy
UOC di Ematologia con trapianto Ospedale S. Maria Goretti
Latina, , Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, , Italy
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
Meldola, , Italy
A.O.U. - Policlinico G. Martino Messina Oncologia Medica - U.O.C. Ematologia
Messina, , Italy
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Mestre, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
Milan, , Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia
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 di Rilievo Nazionale "A. Cardarelli"
Napoli, , Italy
Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, , Italy
S.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
Novara, , Italy
U.O. CTMO Ematologia - Osp. S.Francesco
Nuoro, , Italy
S.C.D.U.Medicina Interna a indirizzo ematologico
Orbassano, , Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padua, , Italy
Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
Pagani, , 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 - A.U. Policlinico "Paolo Giaccone"
Palermo, , Italy
Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1
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
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, , Italy
U.O. Ematologia - AUSL Ospedale G. da Saliceto
Piacenza, , Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, , Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, , Italy
Ospedale "Infermi"
Rimini, , Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza II Facoltà di Medicina e Chirurgia
Roma, , Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, , Italy
Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
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 Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, , Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia
Roma, , Italy
Università degli Studi - Policlinico di Tor Vergata
Roma, , Italy
Sezione di Ematologia Cancer Center Humanitas
Rozzano, , Italy
UOC di Ematologia - 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 - A.O. Senese - Policlinico " Le Scotte"
Siena, , Italy
U.O.C. di Ematologia - A.O. " SS Annunziata" - P.O. S.G. Moscati
Taranto, , Italy
Divisione di Ematologia dell'Università di Torino - "Città della Salute e della Scienza"
Torino, , Italy
Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale
Torino, , Italy
S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino, , Italy
Struttura Complessa Ematologia - Azienda Ospedaliera Universitaria Integrata-Ospedale Maggiore
Trieste, , Italy
Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, , Italy
ULSS N.6 Osp. S. Bortolo
Vicenza, , Italy
Countries
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References
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Bassan R, Chiaretti S, Della Starza I, Santoro A, Spinelli O, Tosi M, Elia L, Cardinali D, De Propris MS, Piccini M, Lussana F, Annunziata M, Chiusolo P, Zappasodi P, Borlenghi E, Leoncin M, Califano C, Bocchia M, Di Raimondo F, Grimaldi F, Tiribelli M, Candoni A, Lico A, Audisio E, Lunghi M, Mianulli AM, Di Trani M, Arena V, Messina M, Piciocchi A, Fazi P, Rambaldi A, Foa R. Up-front blinatumomab improves MRD clearance and outcome in adult Ph- B-lineage ALL: the GIMEMA LAL2317 phase 2 study. Blood. 2025 May 22;145(21):2447-2459. doi: 10.1182/blood.2024027500.
Related Links
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GIMEMA Foundation website
Other Identifiers
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LAL2317
Identifier Type: -
Identifier Source: org_study_id
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