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Lymphoblastic Leukemia, AcutePhase 2NCT00391989

Treatment of Adult Ph+ LAL With BMS-354825

A Phase 2 study testing Dasatinib in people with Lymphoblastic Leukemia, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 36 sites in Italy.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoblastic Leukemia, Acute
What is being tested?
Dasatinib
How many people
53 participants
Where
36 sitesItaly
Study dates
Sep 2006to Sep 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients with Ph+ and/or BCR/ABL+ ALL
  • Age ≥18 years old
  • De novo ALL (within 14 days from diagnosis)
  • 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
  • Absence of central nervous system (CNS) leukemia
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  • Normal serum level of potassium, total calcium corrected for serum albumin magnesium and phosphorus, or correctable with supplements
  • 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.

Who cannot join

  • Impaired cardiac function, including any one of the following:
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BMS-354825 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, 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, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM¬CSF) ≤1 week prior to starting study drug
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  • Patients who are currently receiving treatment with any of the medications listed in "Appendix F" and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in "Appendix F" have the potential to prolong the QT interval.
  • Patients who have received any anti-leukemic 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 breast feeding, 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 BMS-354825). Post-menopausal women must be amenorrheic 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Italy36 sites

  • Nuovo Ospedale "Torrette"

    Ancona

  • Ospedale San Donato USL 8

    Arezzo, Arezzo

  • Presidio Ospedaliero "C. e G.Mazzoni"

    Ascoli Piceno

  • Università degli Studi di Bari

    Bari, Bari

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

    Bologna, Bologna

  • Azienda Spedali Civili

    Brescia, Brescia

  • Osp. Reg. A. Di Summa

    Brindisi, Brindisi

  • Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi

    Cagliari, Cagliari

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

    Catania, Catania

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, Catanzaro

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

    Ferrara, Ferrara

  • Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

    Genova, Genova

  • Ospedale Niguarda " Ca Granda"

    Milan, Milano

  • Sez. di medicina Interna Oncologia ed Ematologia

    Modena, Modena

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Div. TERE

    Naples, Napoli

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples, Napoli

  • Ematologia Università Federico II

    Naples, Napoli

  • Ospedale S. Luigi Gonzaga

    Orbassano, Orbassano

  • Dip. Oncologico "La Maddalena"

    Palermo, Palermo

  • Div. di Ematologia - A.O. "V. Cervello"

    Palermo, Palermo

  • Università degli Studi di Palermo - A.U. Policlinico

    Palermo, Palermo

  • Div. di Ematologia IRCCS Policlinico S. Matteo

    Pavia, Pavia

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

    Pescara, Pescara

  • Istituto di Ematologia- Ospedale San Carlo

    Potenza, Potenza

  • Ospedale S.Maria delle Croci

    Ravenna, Ravenna

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

    Reggio Calabria, Reggio Calabria

  • Ospedale S. Camillo

    Rome, Rome

  • Ospedale S.Eugenio

    Rome, Rome

  • Università Cattolica del Sacro Cuore

    Rome, Rome

  • Università degli Studi di Roma "La Sapienza"

    Rome, Rome

  • Università degli Studi di Tor Vergata

    Rome, Rome

  • Ospedale Sant'Anna-17

    Ronciglione, Viterbo

  • Ospedale Casa Sollievo della sofferenza

    San Giovanni Rotondo

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari, Sassari

  • Policlinico Universitario

    Udine, Udine

  • Policlinico G.B. Rossi

    Verona, Verona

Other trials in Italy

About this study

Official title: A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) With the Protein Tyrosine Kinase Inhibitor BMS-354825. EudraCT Number 2005-005107-42.

The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.

Read the detailed description

This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.

Being tested
Dasatinib
Keywords
Ph+ Acute Lymphoblastic Leukaemia, Dasatinib, targeted therapy, Patients with Ph positive and or BCR ABL positive ALL
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.

What is being measured

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

  1. Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).

    Measured: End of the study, up to day 85

Secondary outcomes (6)

  1. The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;

    Measured: End of study

  2. The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;

    Measured: End of study

  3. the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;

    Measured: End of study

  4. DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;

    Measured: End of study

  5. the Cumulative Incidence of Relapse;

    Measured: End of study

  6. OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.

    Measured: End of study

Timeline

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

  1. First posted25 Oct 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionSep 2008
  4. Study completionSep 2008

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391989
Sponsor's protocol ID
LAL1205
Status last verified
Nov 2016
First submitted
24 Oct 2006
Last updated
4 Jan 2017

Publications

  • Foa R, Vitale A, Vignetti M, Meloni G, Guarini A, De Propris MS, Elia L, Paoloni F, Fazi P, Cimino G, Nobile F, Ferrara F, Castagnola C, Sica S, Leoni P, Zuffa E, Fozza C, Luppi M, Candoni A, Iacobucci I, Soverini S, Mandelli F, Martinelli G, Baccarani M; GIMEMA Acute Leukemia Working Party. Dasatinib as first-line treatment for adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood. 2011 Dec 15;118(25):6521-8. doi: 10.1182/blood-2011-05-351403. Epub 2011 Sep 19.

    PubMed 21931113

  • Messina M, Chiaretti S, Iacobucci I, Tavolaro S, Lonetti A, Santangelo S, Elia L, Papayannidis C, Paoloni F, Vitale A, Guarini A, Martinelli G, Foa R. AICDA expression in BCR/ABL1-positive acute lymphoblastic leukaemia is associated with a peculiar gene expression profile. Br J Haematol. 2011 Mar;152(6):727-32. doi: 10.1111/j.1365-2141.2010.08449.x. Epub 2011 Jan 31.

    PubMed 21623761

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Lymphoblastic Leukemia, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 36 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 14 inclusion and 14 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug). (time frame: End of the study, up to day 85). 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 NCT00391989, 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 4 Jan 2017.

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