Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia (LAL2317)

January 21, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • AOU Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
      • Ascoli Piceno, Italy
        • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
      • Avellino, Italy
        • Az.Ospedaliera S.G.Moscati
      • Bari, Italy
        • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
      • Bari, Italy
        • UOC di Ematologia - Istituto Tumori - Giovanni Paolo II
      • Barletta, Italy
        • UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
      • Bergamo, Italy
        • Azienda Ospedaliera - Papa Giovanni XXIII
      • Bologna, Italy
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinico S. Orsola - Malpighi
      • Bolzano, Italy
        • Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio
      • Brescia, Italy
        • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
      • Brindisi, Italy
        • Divisione di Ematologia Ospedale A. Perrino
      • Cagliari, Italy
        • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
      • Catania, Italy
        • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
      • Cuneo, Italy
        • S.C. Ematologia ASO S. Croce e Carle
      • Firenze, Italy
        • Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio
      • Genova, Italy
        • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
      • Latina, Italy
        • UOC di Ematologia con trapianto Ospedale S. Maria Goretti
      • Lecce, Italy
        • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
      • Meldola, Italy
        • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
      • Messina, Italy
        • A.O.U. - Policlinico G. Martino Messina Oncologia Medica - U.O.C. Ematologia
      • Mestre, Italy
        • U.O. di Ematologia- Ospedale dell'Angelo - Mestre
      • Milano, Italy
        • U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
      • Milano, Italy
        • Ospedale Niguarda " Ca Granda" - SC Ematologia
      • Modena, Italy
        • UO Ematologia - AOU Policlinico di Modena
      • Napoli, Italy
        • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
      • Napoli, Italy
        • Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Novara, Italy
        • S.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
      • Nuoro, Italy
        • U.O. CTMO Ematologia - Osp. S.Francesco
      • Orbassano, Italy
        • S.C.D.U.Medicina Interna a indirizzo ematologico
      • Padova, Italy
        • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
      • Pagani, Italy
        • Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
      • Palermo, 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"
      • Parma, Italy
        • Day Hospital dell'U.O.C di Ematologia e CTMO Padiglione 1
      • Pavia, Italy
        • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
      • Perugia, Italy
        • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
      • Pescara, Italy
        • U.O. Ematologia Clinica - Azienda USL di Pescara
      • Piacenza, Italy
        • U.O. Ematologia - AUSL Ospedale G. da Saliceto
      • Ravenna, Italy
        • Dipartimento Oncologico - Ospedale S.Maria delle Croci
      • Reggio Calabria, Italy
        • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
      • Rimini, Italy
        • Ospedale "Infermi"
      • Roma, Italy
        • Complesso Ospedaliero S. Giovanni Addolorata
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy
        • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
      • Roma, Italy
        • Università degli Studi - Policlinico di Tor Vergata
      • Roma, Italy
        • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
      • Roma, Italy
        • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza II Facoltà di Medicina e Chirurgia
      • Roma, Italy
        • U.O.C. Ematologia - Ospedale S. Eugenio
      • Roma, Italy
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia
      • Rozzano, Italy
        • Sezione di Ematologia Cancer Center Humanitas
      • Salerno, Italy
        • UOC di Ematologia - AOU San Giovanni di Dio e Ruggi D'Aragona
      • San Giovanni Rotondo, Italy
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Siena, Italy
        • U.O.C. Ematologia - A.O. Senese - Policlinico " Le Scotte"
      • Taranto, Italy
        • U.O.C. di Ematologia - A.O. " SS Annunziata" - P.O. S.G. Moscati
      • Torino, Italy
        • S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
      • Torino, 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
      • Trieste, Italy
        • Struttura Complessa Ematologia - Azienda Ospedaliera Universitaria Integrata-Ospedale Maggiore
      • Udine, Italy
        • Clinica Ematologica-Centro Trapianti e Terapie cellulari AOU,
      • Verona, Italy
        • Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
      • Vicenza, Italy
        • ULSS N.6 Osp. S. Bortolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Chemotherapy + Blinatumomab
Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients that obtain a negative Minimal Residual Disease (MRD)
Time Frame: At week 14 from study entry
At week 14 from study entry

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients in complete remission (CR)
Time Frame: At 32 months from study entry
At 32 months from study entry
Number of patients that reach disease-free survial
Time Frame: At 32 months from study entry
At 32 months from study entry
Number of patients that relapse
Time Frame: At 32 months from study entry
At 32 months from study entry
Number of patients that dye due to treatment
Time Frame: At 32 months from study entry
Treatment-related mortality
At 32 months from study entry
Number of serious adverse events
Time Frame: At 32 months from study entry
Safety
At 32 months from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Renato Bassan, Azienda ULSS 12 "Veneziana" U.O. Ematologia Direttore Renato Bassan
  • Study Director: Roberto Foà, Policlinico Umberto I, Hematology Department.
  • Study Director: Alessandro Rambaldi, Ospedale di Bergamo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LAL2317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Lymphoid Leukemia

Clinical Trials on Chemotherapy + Blinatumomab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings