D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia

March 21, 2018 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
60

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Ascoli Piceno, Italy
        • Not yet recruiting
        • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
      • Avellino, Italy
        • Not yet recruiting
        • Az.Ospedaliera S.G.Moscati
        • Contact:
          • Nicola Cantore
        • Principal Investigator:
          • Nicola Cantore
      • Bari, Italy
        • Not yet recruiting
        • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
        • Contact:
          • Giorgina Specchia
        • Principal Investigator:
          • Giorgina Specchia
      • Bergamo, Italy
        • Recruiting
        • Azienda Ospedaliera - Papa Giovanni XXIII
        • Contact:
          • Alessandro Rambaldi
        • Principal Investigator:
          • Alessandro Rambaldi
      • Bologna, Italy
        • Not yet recruiting
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
        • Contact:
          • Giovanni Martinelli
        • Principal Investigator:
          • Giovanni Martinelli
      • Brindisi, Italy
        • Not yet recruiting
        • Divisione di Ematologia Ospedale A. Perrino
        • Contact:
          • Angela Melpignano
        • Principal Investigator:
          • Angela Melpignano
      • Catania, Italy
        • Recruiting
        • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
      • Firenze, Italy
        • Not yet recruiting
        • Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
        • Contact:
          • Alberto Bosi
      • Genova, Italy
        • Not yet recruiting
        • Unità Operative Complesse di Ematologia 1 e 2 Centro Trapianti di Midollo dell'IRCCS AOU San Martino-IST
        • Contact:
          • Angelo Michele Carella
        • Principal Investigator:
          • Angelo Michele Carella
      • Lecce, Italy
        • Not yet recruiting
        • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
        • Principal Investigator:
          • Nicola Di Renzo
      • Mestre, Italy
        • Recruiting
        • U.O. di Ematologia- Ospedale dell'Angelo - Mestre
        • Principal Investigator:
          • Renato Bassan
        • Contact:
          • Renato Bassan
      • Milano, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
        • Contact:
          • Agostino Cortelezzi
        • Principal Investigator:
          • Agostino Cortelezzi
      • Milano, Italy
        • Not yet recruiting
        • Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
        • Contact:
          • Valentina Mancini
        • Principal Investigator:
          • Valentina Mancini
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
        • Contact:
          • Felicetto Ferrara
        • Principal Investigator:
          • Delicetto Ferrara
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Novara, Italy
        • Recruiting
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
        • Principal Investigator:
          • Gianluca Gaidano
      • Orbassano, Italy
        • Recruiting
        • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
        • Contact:
          • Giovanna Rege
        • Principal Investigator:
          • Giovanna Rege
      • Pagani, Italy
        • Recruiting
        • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
        • Contact:
          • Castello Califano
        • Principal Investigator:
          • Castello Califano
      • Palermo, Italy
        • Recruiting
        • Ospedali Riuniti "Villa Sofia-Cervello"
        • Contact:
          • Francesco Fabbiano
        • Principal Investigator:
          • Francesco Fabbiano
      • Perugia, Italy
        • Recruiting
        • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
        • Contact:
          • Brunangelo Falini
        • Principal Investigator:
          • Brunangelo Falini
      • Pescara, Italy
        • Not yet recruiting
        • Ematologia Clinica - Azienda USL di Pescara
        • Contact:
          • Paolo Di Bartolomeo
        • Principal Investigator:
          • Paolo Di Bartolomeo
      • Reggio Calabria, Italy
        • Not yet recruiting
        • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
        • Contact:
          • Francesca Ronco
        • Principal Investigator:
          • Francesca Ronco
      • Roma, Italy
        • Recruiting
        • Complesso Ospedaliero S. Giovanni Addolorata
        • Contact:
          • Anna Chierichini
        • Principal Investigator:
          • Anna Chierichini
      • Roma, Italy
        • Recruiting
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
        • Contact:
          • Simona C Sica
      • Roma, Italy
        • Not yet recruiting
        • Università degli Studi - Policlinico di Tor Vergata
        • Contact:
          • Adriano Venditti
        • Principal Investigator:
          • Adriano Venditti
      • Roma, Italy
        • Not yet recruiting
        • UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini
        • Contact:
          • Stefano C Mancini
        • Principal Investigator:
          • Stefano Mancini
      • Rome, Italy
        • Not yet recruiting
        • Policlinico Umberto I, Hematology Department
      • Rome, Italy
        • Recruiting
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Rozzano, Italy
        • Not yet recruiting
        • Sezione di Ematologia Cancer Center Humanitas
        • Contact:
          • Matteo Della Porta
        • Principal Investigator:
          • Matteo Della Porta
      • San Giovanni Rotondo, Italy
        • Not yet recruiting
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Torino, Italy
        • 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, Italy
        • Not yet recruiting
        • Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale Torino
        • Contact:
          • Alessandro Cignetti
        • Principal Investigator:
          • Alessandro Cignetti
      • Torino, Italy
        • Not yet recruiting
        • Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale
        • Contact:
          • Alessandro Cignetti
        • Principal Investigator:
          • Alessandro Cignetti
      • Verona, Italy
        • Recruiting
        • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
        • Contact:
          • Massimiliano Bonifacio

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).
    • 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:

  • 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.
    • 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.

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: 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.
Drug: 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.
Drug: 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.

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
Measure Description
Time Frame
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)
After 11 months 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
Time Frame
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
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
At day +22, +45, +57 and +85 from study entry
Number of months of the CMR
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of patients in Overall Survival (OS)
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of grade >3 adverse events
Time Frame: At 12 and 24 months
At 12 and 24 months

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: Roberto Foà, Policlinico Umberto I, Hematology Department.

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.

General Publications

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.
May 31, 2017

Primary Completion (Anticipated)

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.
June 1, 2021

Study Completion (Anticipated)

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.
June 1, 2021

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).
April 11, 2016

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.
April 18, 2016

First Posted (Estimate)

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.
April 20, 2016

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 22, 2018

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.
March 21, 2018

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.
March 1, 2018

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.
  • LAL2116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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