D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia
NCT ID: NCT02744768
Last Updated: 2018-03-22
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2017-05-31
2021-06-30
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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Treatment
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84. Prednisone (PDN) will be administered from day -6 to day +0 (during which the presence of the BCR/ABL1 alteration will be established), at escalating doses up to 60 mg/m2; PDN will be continued up to day +24 and progressively tapered up to day +31.
HLA typing will be performed immediately after the diagnosis for eligible patients.
MRD will be evaluated by RT-PCR at fixed time points (days +22, +45, +57) during the induction and at day +85, the latter for molecular response evaluation.
Dasatinib
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.
Blinatumomab
Upon induction:
patients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary.
Interventions
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Dasatinib
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.
Blinatumomab
Upon induction:
patients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary.
Eligibility Criteria
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Inclusion Criteria
* Age greater or equal to18 years,
* Signed written informed consent according to ICH/EU/GCP and national local laws.
* ECOG Performance Status 0 or 1 and/or WHO performance status less or equal to 2.
* Renal and hepatic function as defined below:
* AST (GOT), ALT (GPT), and AP \<2 x upper limit of normal (ULN).
* Total bilirubin \<1.5 x ULN.
* Creatinine clearance equal or greater than 50 mL/min.
* Pancreatic function as defined below:
* Serum amylase less or equal to 1.5 x ULN
* Serum lipase less or equal to1.5 x ULN.
* Normal cardiac function.
* Negative HIV test, negative HBV DNA and HCV RNA.
* Negative pregnancy test in women of childbearing potential.
* Bone marrow specimen from primary diagnosis available.
Exclusion Criteria
* Impaired cardiac function, including any one of the following:
* LVEF \<45% as determined by MUGA scan or echocardiogram.
* Complete left bundle branch block.
* Use of a cardiac pacemaker.
* ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.
* Congenital long QT syndrome.
* History of or presence of significant ventricular or atrial arrhythmia.
* Clinically significant resting bradycardia (\<50 beats per minute).
* QTc \>450 msec on screening ECG (using the QTcF formula).
* Right bundle branch block plus left anterior hemiblock, bifascicular block.
* Myocardial infarction within 3 months prior to starting Dasatinib.
* Angina pectoris.
* Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
* History of or current autoimmune disease.
* Systemic cancer chemotherapy within 2 weeks prior to study.
* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
* Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.
* Active infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator.
* Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
18 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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Roberto Foà
Role: STUDY_CHAIR
Policlinico Umberto I, Hematology Department.
Locations
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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
Divisione di Ematologia Ospedale A. Perrino
Brindisi, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, , Italy
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence, , Italy
Unità Operative Complesse di Ematologia 1 e 2 Centro Trapianti di Midollo dell'IRCCS AOU San Martino-IST
Genova, , Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, , Italy
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Mestre, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan, , Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, , Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, , Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano, , Italy
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
Pagani, , Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, , Italy
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
Perugia, , Italy
Ematologia Clinica - Azienda USL di Pescara
Pescara, , Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, , Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, , Italy
Università degli Studi - Policlinico di Tor Vergata
Roma, , Italy
UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Policlinico Umberto I, Hematology Department
Rome, , Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Rome, , Italy
Sezione di Ematologia Cancer Center Humanitas
Rozzano, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , 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
Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale Torino
Torino, , Italy
Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale
Torino, , 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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Central Contacts
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Facility Contacts
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Piero Galieni
Role: primary
Nicola Cantore
Role: primary
Giorgina Specchia
Role: primary
Alessandro Rambaldi
Role: primary
Giovanni Martinelli
Role: primary
Angela Melpignano
Role: primary
Francesco Di Raimondo
Role: primary
Alberto Bosi
Role: primary
Angelo Michele Carella
Role: primary
Nicola Di Renzo
Role: primary
Renato Bassan
Role: primary
Agostino Cortelezzi
Role: primary
Valentina Mancini
Role: primary
Felicetto Ferrara
Role: primary
Fabrizio Pane
Role: primary
Gianluca Gaidano
Role: primary
Giovanna Rege
Role: primary
Castello Califano
Role: primary
Francesco Fabbiano
Role: primary
Brunangelo Falini
Role: primary
Paolo Di Bartolomeo
Role: primary
Francesca Ronco
Role: primary
Anna Chierichini
Role: primary
Simona C Sica
Role: primary
Adriano Venditti
Role: primary
Stefano C Mancini
Role: primary
Roberto Foà
Role: primary
Roberto Foà
Role: primary
Matteo Della Porta
Role: primary
Nicola Cascavilla
Role: primary
Ernesta Audisio
Role: primary
Alessandro Cignetti
Role: primary
Alessandro Cignetti
Role: primary
Massimiliano Bonifacio
Role: primary
References
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Foa R, Bassan R, Elia L, Piciocchi A, Soddu S, Messina M, Ferrara F, Lunghi M, Mule A, Bonifacio M, Fracchiolla N, Salutari P, Fazi P, Guarini A, Rambaldi A, Chiaretti S. Long-Term Results of the Dasatinib-Blinatumomab Protocol for Adult Philadelphia-Positive ALL. J Clin Oncol. 2024 Mar 10;42(8):881-885. doi: 10.1200/JCO.23.01075. Epub 2023 Dec 21.
Foa R, Bassan R, Vitale A, Elia L, Piciocchi A, Puzzolo MC, Canichella M, Viero P, Ferrara F, Lunghi M, Fabbiano F, Bonifacio M, Fracchiolla N, Di Bartolomeo P, Mancino A, De Propris MS, Vignetti M, Guarini A, Rambaldi A, Chiaretti S; GIMEMA Investigators. Dasatinib-Blinatumomab for Ph-Positive Acute Lymphoblastic Leukemia in Adults. N Engl J Med. 2020 Oct 22;383(17):1613-1623. doi: 10.1056/NEJMoa2016272.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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GIMEMA Foundation website
Other Identifiers
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LAL2116
Identifier Type: -
Identifier Source: org_study_id
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