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ALL Ph PositivePhase 2LAL1509NCT01361438

De Novo Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients

A Phase 2 study testing Total therapy approach in people with ALL Ph Positive, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 51 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18 years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to starting Dasatinib and will continue up to day 31. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
ALL Ph Positive
What is being tested?
Total therapy approach
How many people
60 participants
Where
51 sitesItaly
Study dates
Jun 2011to Dec 2020
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with de novo Ph+ and/or BCR/ABL+ ALL.
  • Age ≥18 years old ≤60 years.
  • No prior treatment with any anti-leukemic drugs with the exception of steroids for no more than 14 days (including the 7-day pretreatment already scheduled in the protocol).
  • WHO performance status ≤2.
  • No evidence of central nervous system (CNS) leukemia.
  • Normal serum level of potassium, total calcium corrected for serum albumin magnesium and phosphorus, or correctable with supplements.
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  • ALT and AST ≤2.5 x ULN or ≤5.0 x ULN if considered due to leukemia.
  • Alkaline phosphatase ≤2.5 x ULN unless considered to leukemia.
  • Serum bilirubin ≤2 x ULN.
  • Serum creatinine ≤3 x ULN.
  • Serum amylase ≤1.5 x ULN and serum lipase ≤1.5 x ULN.
  • Normal cardiac function.
  • Written informed consent prior to any study procedures being performed. In addition, patients must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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).
  • Use of therapeutic warfarin.
  • Acute or chronic liver or renal disease considered unrelated to leukemia.
  • Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Active uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF) ≤1 week prior to starting study drug.
  • Patients who are currently receiving treatment with any of the medications listed in "Appendix H" and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in "Appendix H" have the potential to prolong the QT interval.
  • Patients who have received any antileukemic agents and treatments including steroids. for more than 14 days including 7 days pretreatment that is part of the protocol.
  • Patients who have received any investigational drug in the last 2 weeks.
  • Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
  • Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of Dasatinib. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
  • Non compliant to oral medication patients.
  • Significant pleural effusion on baseline chest X-Ray (CXR) or pericardial effusion on baseline echocardiogram.
  • Use of H2 blockers or proton pump inhibitors.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Italy51 sites

  • Azienda Ospedaliera - Nuovo Ospedale "Torrette"

    Ancona

  • Dipartimento Area Medica P.O.

    Ascoli Piceno, 63100

  • Az. Ospedaliera S. G. Moscati

    Avellino

  • Unità Operativa Ematologia 1 - Università degli Studi di Bari

    Bari, 70010

  • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli

    Bologna

  • Osp. Reg. A. Di Summa

    Brindisi

  • CTMO - Ematologia - Ospedale "Binaghi"

    Cagliari

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

    Catania

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

  • U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza

    Cosenza

  • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna

    Ferrara, 44100

  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

    Foggia

  • Clinica Ematologica - Università degli Studi

    Genova

  • Divisione di Ematologia Ospedale "Santa Maria Goretti"

    Latina

  • ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia

    Lecce, 73100

  • Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" di Messina

    Messina

  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

    Messina

  • Ospedale Niguarda " Ca Granda"

    Milan

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

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

    Naples

  • Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE

    Naples

  • Prof. D'Arco

    Nocera Inferiore

  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

    Novara

  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga

    Orbassano

  • Ospedale Cervello

    Palermo, 90146

  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

    Palermo

  • La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello

    Palermo

  • Div. di Ematologia IRCCS Policlinico S. Matteo

    Pavia, 27100

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

    Pescara

  • Università di Pisa Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Div. di Ematologia

    Pisa

  • Ematologia - Ospedale San Carlo

    Potenza

  • Ospedale S.Maria delle Croci

    Ravenna, 48100

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

    Reggio Calabria

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

  • Centro Oncologico Basilicata

    Rionero in Vulture, Potenza

  • Divisione Ematologia - Università Campus Bio-Medico

    Roma, 00128

  • Umberto I di Roma - Dipartimento di Biotecnologie Cellulari ed Ematologia

    Roma, 00161

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

    Roma

  • Complesso Ospedaliero S. Giovanni Addolorata

    Roma

  • Divisione di Ematologia - Ospedale S. Camillo

    Roma

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

    Roma

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma

  • Policlinico di Tor Vergata

    Rome, 00133

  • Ospedale S.Eugenio

    Rome, 00144

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari

  • Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani

    Trani

  • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico

    Tricase

  • Policlinico Universitario - Clinica Ematologia

    Udine, 33100

  • Policlinico G.B. Rossi

    Verona, 37134

Other trials in Italy

About this study

Official title: A Multicenter Total Therapy Strategy for De Novo Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients. GIMEMA Protocol LAL1509, EudraCT Number 2010-019119-39

This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18 years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to starting Dasatinib and will continue up to day 31. Patients will continue treatment with Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal from study.

Read the detailed description

This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18 years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to starting Dasatinib and will continue up to day 31. Patients will continue treatment with Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal from study.

Thereafter:

  • patients in hematological and molecular CR will receive a post-remissional treatment consisting of Dasatinib alone for a 6 months period
  • patients in hematological CR with persistence of molecular disease will be allografted or, if not eligible or a donor is not available, treated with 2 cycles of a Clofarabine-Cyclophosphamide schedule.

After allograft:

  • MRD negative patients (i.e. in CHR and PCR negative) will receive a 6 months Dasatinib maintenance treatment;
  • MRD positive patients (i.e. in CHR and PCR positive) will receive Dasatinib as maintenance treatment until relapse or progression.

Patients not transplanted and treated with Clofarabine/Cyclophosphamide will also receive Dasatinib as maintenance treatment until relapse or progression.

Conditions
ALL Ph Positive
Being tested
Total therapy approach

What participants receive

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

  • Total therapy approachOther

    Total therapy approach

What is being measured

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

  1. The primary objective of the trial is to estimate the feasibility of a total therapy strategy in de novo adult Ph positive ALL.

    The primary endpoint is the rate of patients alive in CHR who have completed the trial treatment according to the therapeutic strategy;

    Measured: at 42 months

Secondary outcomes (8)

  1. The median value of the minimum of PCR levels achieved in each patient during the Dasatinib treatment within day +85, whenever achieved from the start of the Dasatinib.

    Measured: at 42 months

  2. The rate of patients who become PCR negative after Dasatinib induction.

    Measured: at 42 months

  3. Out of patients who become PCR negative after induction, the rate of patients who remain persistently negative during maintenance treatment with Dasatinib (without chemotherapy or allogeneic transplant).

    Measured: at 42 months

  4. The median value of the minimum of PCR levels achieved in each patient after an allogeneic transplant or Clofarabine-Cyclophosphamide treatment as consolidation therapy.

    Measured: at 42 months

  5. The rate of patients alive in CHR who have completed the maintenance program with Dasatinib after an allogeneic transplant or two cycles of Clofarabine-Cyclophosphamide as consolidation therapy.

    Measured: at 42 months

  6. Disease free survival estimation starting from the date of evaluation of CHR.

    Measured: at 42 months

  7. Cumulative incidence of relapse estimation starting from the date of evaluation of CHR.

    Measured: at 42 months

  8. Overall survival estimation starting from date of inclusion.

    Measured: at 42 months

Timeline

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

  1. First posted26 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionOct 2014
  4. Study completionDec 2020 (estimated)

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01361438
Sponsor's protocol ID
LAL1509
Acronym
LAL1509
Status last verified
Oct 2020
First submitted
13 May 2011
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Total therapy approach in people with ALL Ph Positive, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 51 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 13 inclusion and 29 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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?

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?

The primary objective of the trial is to estimate the feasibility of a total therapy strategy in de novo adult Ph positive ALL. (time frame: at 42 months). 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 NCT01361438.

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 8 Oct 2020.

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