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AzTrials

Acute Lymphoid LeukemiaPhase 2LAL2317NCT03367299

Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia

A Phase 2 study testing Chemotherapy + Blinatumomab in people with Acute Lymphoid Leukemia and Philadelphia Chromosome-Negative B-Cell Precursor, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 62 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Chemotherapy + Blinatumomab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
62 sitesItaly
Study dates
8 Jun 2018to 2 Sep 2024
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • 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.

Who cannot join

  • Diagnosis of Burkitt's leukemia/lymphoma, CD19- BCP ALL, Ph+ ALL, T-ALL, lymphoblastic lymphoma (BM involvement by blast cells <25%).
  • 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.

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

Italy62 sites

  • AOU Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

    Ancona

  • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno

    Ascoli Piceno

  • Az.Ospedaliera S.G.Moscati

    Avellino

  • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

    Bari

  • UOC di Ematologia - Istituto Tumori - Giovanni Paolo II

    Bari

  • UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"

    Barletta

  • Azienda Ospedaliera - Papa Giovanni XXIII

    Bergamo

  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinico S. Orsola - Malpighi

    Bologna

  • Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio

    Bolzano

  • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia

    Brescia

  • Divisione di Ematologia Ospedale A. Perrino

    Brindisi

  • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

    Cagliari

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

  • S.C. Ematologia ASO S. Croce e Carle

    Cuneo

  • Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio

    Florence

  • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

    Genova

  • UOC di Ematologia con trapianto Ospedale S. Maria Goretti

    Latina

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

    Lecce

  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

    Meldola

  • A.O.U. - Policlinico G. Martino Messina Oncologia Medica - U.O.C. Ematologia

    Messina

  • U.O. di Ematologia- Ospedale dell'Angelo - Mestre

    Mestre

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia

    Milan

  • Ospedale Niguarda " Ca Granda" - SC Ematologia

    Milan

  • U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele

    Milan

  • UO Ematologia - AOU Policlinico di Modena

    Modena

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

  • Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

    Naples

  • S.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro

    Novara

  • U.O. CTMO Ematologia - Osp. S.Francesco

    Nuoro

  • S.C.D.U.Medicina Interna a indirizzo ematologico

    Orbassano

  • Università degli Studi di Padova - Ematologia ed Immunologia Clinica

    Padova

  • Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

    Pagani

  • Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo

  • 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

  • Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1

    Parma

  • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

    Pavia

  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia

    Perugia

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara

  • U.O. Ematologia - AUSL Ospedale G. da Saliceto

    Piacenza

  • Dipartimento Oncologico - Ospedale S.Maria delle Croci

    Ravenna

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • Ospedale "Infermi"

    Rimini

  • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza II Facoltà di Medicina e Chirurgia

    Roma

  • Complesso Ospedaliero S. Giovanni Addolorata

    Roma

  • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo

    Roma

  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

    Roma

  • U.O.C. Ematologia - Ospedale S. Eugenio

    Roma

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia

    Roma

  • Università degli Studi - Policlinico di Tor Vergata

    Roma

  • Sezione di Ematologia Cancer Center Humanitas

    Rozzano

  • UOC di Ematologia - AOU San Giovanni di Dio e Ruggi D'Aragona

    Salerno

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • U.O.C. Ematologia - A.O. Senese - Policlinico " Le Scotte"

    Siena

  • U.O.C. di Ematologia - A.O. " SS Annunziata" - P.O. S.G. Moscati

    Taranto

  • Divisione di Ematologia dell'Università di Torino - "Città della Salute e della Scienza"

    Torino

  • Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale

    Torino

  • S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

    Torino

  • Struttura Complessa Ematologia - Azienda Ospedaliera Universitaria Integrata-Ospedale Maggiore

    Trieste

  • Clinica Ematologica-Centro Trapianti e Terapie cellulari AOU,

    Udine

  • Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

    Verona

  • ULSS N.6 Osp. S. Bortolo

    Vicenza

Other trials in Italy

About this study

Official title: National Treatment Program With Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-Negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia

The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab.

Read the detailed description

Eligible patients with CD19+ Ph- BCP ALL (Philadelphia-negative B-cell precursor acute lymphoblastic leukemia) will receive homogeneous supportive care, chemotherapy and blinatumomab immunotherapy, and will be homogeneously analyzed for response at prefixed time points from induction day 1. For risk-oriented therapy, patients in complete remission (CR) will be stratified by risk class according to the diagnostic characteristics and MRD (minimal residual disease) study results during early consolidation.

Being tested
Chemotherapy + Blinatumomab
Keywords
Acute Lymphoid Leukemia, Philadelphia Chromosome-Negative B-Cell Precursor, Adults, Minimal residual disease, Blinatumomab
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemotherapy + BlinatumomabDrug

    Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.

Study groups in NCT03367299
Study groupRoleWhat they receive
Chemotherapy + BlinatumomabExperimentalTreatment sequence consists of eight chemotherapy courses and two blinatumomab courses. Patients not in CR after chemotherapy course 2 will go off-study.
Receives: Drug: Chemotherapy + Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients that obtain a negative Minimal Residual Disease (MRD)

    Measured: At week 14 from study entry

Secondary outcomes (5)

  1. Number of patients in complete remission (CR)

    Measured: At 32 months from study entry

  2. Number of patients that reach disease-free survial

    Measured: At 32 months from study entry

  3. Number of patients that relapse

    Measured: At 32 months from study entry

  4. Number of patients that dye due to treatment

    Treatment-related mortality

    Measured: At 32 months from study entry

  5. Number of serious adverse events

    Safety

    Measured: At 32 months from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start8 Jun 2018
  3. Primary completion2 Sep 2024
  4. Study completion2 Sep 2024

Resources

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
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367299
Sponsor's protocol ID
LAL2317
Acronym
LAL2317
Status last verified
Jan 2025
First submitted
5 Dec 2017
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40009490

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy + Blinatumomab in people with Acute Lymphoid Leukemia and Philadelphia Chromosome-Negative B-Cell Precursor, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 62 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients that obtain a negative Minimal Residual Disease (MRD) (time frame: At week 14 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 NCT03367299, which also lists 1 linked publication.

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 Jan 2025.

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