Acute Lymphoblastic LeukemiaPhase 2NCT02744768
D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia
A Phase 2 study testing Dasatinib and Blinatumomab in people with Acute Lymphoblastic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 34 sites in Italy.
Trial summary
This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Dasatinib and Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 34 sitesItaly
- Study dates
- 31 May 2017to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed adult B-precursor Ph+ ALL patients.
- 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).
Show all 15Show fewer
- 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.
Who cannot join
- History of or current relevant CNS pathology (current ≥grade 2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson's disease, organic brain syndrome, psychosis).
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Italy34 sites, 34 recruiting
- Not yet recruiting
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno
Piero Galieni
Piero Galieni
- Not yet recruiting
Az.Ospedaliera S.G.Moscati
Avellino
Nicola Cantore
Nicola Cantore
- Not yet recruiting
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Giorgina Specchia
Giorgina Specchia
- Recruiting
Azienda Ospedaliera - Papa Giovanni XXIII
Bergamo
Alessandro Rambaldi
Alessandro Rambaldi
- Not yet recruiting
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
Giovanni Martinelli
Giovanni Martinelli
- Not yet recruiting
Divisione di Ematologia Ospedale A. Perrino
Brindisi
Angela Melpignano
Angela Melpignano
- Recruiting
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania
Francesco Di Raimondo
Francesco Di Raimondo
- Not yet recruiting
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence
Alberto Bosi
- Not yet recruiting
Unità Operative Complesse di Ematologia 1 e 2 Centro Trapianti di Midollo dell'IRCCS AOU San Martino-IST
Genova
Angelo Michele Carella
Angelo Michele Carella
- Not yet recruiting
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
Nicola Di Renzo
Nicola Di Renzo
- Recruiting
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Mestre
Renato Bassan
Renato Bassan
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan
Agostino Cortelezzi
Agostino Cortelezzi
- Not yet recruiting
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milan
Valentina Mancini
Valentina Mancini
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples
Felicetto Ferrara
Delicetto Ferrara
- Recruiting
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Fabrizio Pane
Fabrizio Pane
- Recruiting
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Gianluca Gaidano
Gianluca Gaidano
- Recruiting
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano
Giovanna Rege
Giovanna Rege
- Recruiting
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
Pagani
Castello Califano
Castello Califano
- Recruiting
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Francesco Fabbiano
Francesco Fabbiano
- Recruiting
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
Perugia
Brunangelo Falini
Brunangelo Falini
- Not yet recruiting
Ematologia Clinica - Azienda USL di Pescara
Pescara
Paolo Di Bartolomeo
Paolo Di Bartolomeo
- Not yet recruiting
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria
Francesca Ronco
Francesca Ronco
- Recruiting
Complesso Ospedaliero S. Giovanni Addolorata
Roma
Anna Chierichini
Anna Chierichini
- Recruiting
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Simona C Sica
Simona Sica
- Not yet recruiting
Università degli Studi - Policlinico di Tor Vergata
Roma
Adriano Venditti
Adriano Venditti
- Not yet recruiting
UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini
Roma
Stefano C Mancini
Stefano Mancini
- Not yet recruiting
Policlinico Umberto I, Hematology Department
Rome
Roberto Foà
Roberto Foà
- Recruiting
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Rome
Roberto Foà
Roberto Foà
- Not yet recruiting
Sezione di Ematologia Cancer Center Humanitas
Rozzano
Matteo Della Porta
Matteo Della Porta
- Not yet recruiting
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Nicola Cascavilla
Nicola Cascavilla
- Not yet recruiting
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino
Ernesta Audisio
Ernesta Audisio
- Not yet recruiting
Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale Torino
Torino
Alessandro Cignetti
Alessandro Cignetti
- Not yet recruiting
Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale
Torino
Alessandro Cignetti
Alessandro Cignetti
- Recruiting
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
Massimiliano Bonifacio
Massimiliano Bonifacio
About this study
Official title: D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab
This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Dasatinib, Blinatumomab
- Keywords
- Acute Lymphoblastic Leukemia, adult, dasatinib, blinatumomab
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
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.
BlinatumomabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: Dasatinib; Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment
In particular, after 2 cycles of blinatumomab. Minimal Residual Disease (MRD) negativity is intended as Complete Molecular Remission (CMR)
Measured: After 11 months from study entry
Secondary outcomes (5)
Number of patients completing the 2 cycles of blinatumomab and alive in first complete hematologic remission (CHR)
Measured: From day +85 at 12 months
Number of patients at Complete Molecular Response (CMR)
Measured: At day +22, +45, +57 and +85 from study entry
Number of months of the CMR
Measured: At 12 and 24 months
Number of patients in Overall Survival (OS)
Measured: At 12 and 24 months
Number of grade >3 adverse events
Measured: At 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start31 May 2017
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Foà, Study chair, Policlinico Umberto I, Hematology Department.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744768
- Sponsor's protocol ID
- LAL2116
- Status last verified
- Mar 2018
- First submitted
- 11 Apr 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38127722Foa 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.
PubMed 33085860
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab
- ClinicalTrials.gov ID
- NCT02744768
- Acronym / sponsor ID
- LAL2116
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, adult, dasatinib, blinatumomab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Dasatinib, Drug: BlinatumomabAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Newly diagnosed adult B-precursor Ph+ ALL patients.
- 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:
Key exclusion criteria (21 listed)
- History of or current relevant CNS pathology (current ≥grade 2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson's disease, organic brain syndrome, psychosis).
- Impaired cardiac function, including any one of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAdult 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. | Drug | Treatment |
| BlinatumomabUpon 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. | Drug | Treatment |
Primary outcome
Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment
Time frame: After 11 months from study entry
In particular, after 2 cycles of blinatumomab. Minimal Residual Disease (MRD) negativity is intended as Complete Molecular Remission (CMR)
5 secondary outcomes
Number of patients completing the 2 cycles of blinatumomab and alive in first complete hematologic remission (CHR)
Time frame: From day +85 at 12 months
Number of patients at Complete Molecular Response (CMR)
Time frame: At day +22, +45, +57 and +85 from study entry
Number of months of the CMR
Time frame: At 12 and 24 months
Number of patients in Overall Survival (OS)
Time frame: At 12 and 24 months
Number of grade >3 adverse events
Time frame: At 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 38127722Foa 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.
- Derived from this study: PubMed 33085860Foa 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.
- GIMEMA Foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Foà study chair
Policlinico Umberto I, Hematology Department.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and Blinatumomab in people with Acute Lymphoblastic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 34 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+39 06.70390521, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment (time frame: After 11 months from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744768, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.