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LeukemiaPhase 2LAL0904NCT00458848

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

A Phase 2 study testing asparaginase, daunorubicin hydrochloride and etoposide in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 66 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

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Leukemia
What is being tested?
asparaginase, daunorubicin hydrochloride and etoposide
Type of treatment
Surgery or procedure
How many people
470 participants
Where
66 sitesItaly
Study dates
Oct 2004to Mar 2014
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 15 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:
  • Negative myeloperoxidase stain
  • Phenotype T (T-ALL) or B (B-ALL)
  • No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)

PATIENT CHARACTERISTICS:

  • Creatinine ≤ 2.5 mg/dL (after adequate hydration)
  • SGOT and SGPT ≤ 3 times upper limit of normal
  • LVEF ≥ 50%
  • No severe psychiatric disorders
  • No other concurrent malignant disease
  • No presence of documented infections not responding to antibiotic and/or antifungal therapy
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • No prior steroids
  • No prior antiblastic chemotherapy
  • No other concurrent chemotherapy or radiotherapy

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

Italy66 sites

  • Ospedale Civile Alessandria

    Alessandria, I-15100

  • Ospedale Torrette University Ancona

    Ancona, 60020

  • Ospedale S. Donato

    Arezzo, 52100

  • Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"

    Ascoli Piceno

  • S.G. Moscati Hospital

    Avellino, 83100

  • Universita Degli Studi di Bari

    Bari, 70124

  • University of Bologna Medical School

    Bologna, 40138

  • Spedali Civili di Brescia

    Brescia, 25123

  • A. Perrino Hospital

    Brindisi, 72100

  • Ospedale Binaghi

    Cagliari, 090100

  • Ospedale Ferrarotto

    Catania, 95124

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

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

    Cosenza

  • Universita di Ferrara

    Ferrara, 44100

  • Azienda Ospedaliera di Firenze

    Florence, 50011

  • Ospedali Riuniti Foggia

    Foggia, 71100

  • Ospedale Umberto I

    Frosinone, 03100

  • Ospedale S. Antonio Abate

    Gallarate, 21013

  • Ospedale San Martino

    Genoa, 16132

  • Ospedale L'Aquila

    L’Aquila, 67100

  • Ospedale Santa Maria Goretti

    Latina, 04100

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

    Lecce

  • Ospedale Maggiore Lodi

    Lodi, I-20075

  • Azienda Ospedaliera Universitaria - Policlinico G. Martino

    Messina, 98125

  • Ospedale Niguarda Ca'Granda

    Milan, 20162

  • Azienda Ospedaliera - Universitaria di Modena

    Modena, 41100

  • Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

    Naples, 80127

  • Federico II University Medical School

    Naples, 80131

  • Ospedale S. Gennaro ASL NA1

    Naples, 80131

  • Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I

    Nocera Inferiore

  • Amedeo Avogadro University of Eastern Piedmont

    Novara, I-28100

  • Ospedale San Francesco

    Nuoro, 08100

  • Azienda Ospedale S. Luigi at University of Torino

    Orbassano, 10043

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Policlinico - Cattedra di Ematologia

    Palermo, 90100

  • Ospedale Cervello

    Palermo, 90146

  • Ospedale La Maddalena - Palermo

    Palermo

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100

  • University of Pavia

    Pavia, 27100

  • Perugia Regional Cancer Center

    Perugia, 06122

  • Azienda Ospedale - d S. Salvatore

    Pesaro, 61100

  • Ospedale Civile Pescara

    Pescara, 65100

  • Azienda Ospedaliera Pisana

    Pisa

  • Azienda Ospedaliera San Carlo - Potenza

    Potenza, 85100

  • Ospedale Sta. Maria Delle Croci

    Ravenna, 48100

  • Ospedale S. M. delle Croci

    Ravenna, I-48100

  • Azienda Ospedaliera Bianchi Melacrino Morelli

    Reggio Calabria, 89100

  • Arcispedale S. Maria Nuova

    Reggio Emilia, 42100

  • Ospedale Oncologico Regionale

    Rionero in Vulture, I-58028

  • Ospedale Sant' Eugenio

    Rome, 00144

  • Azienda Ospedaliera S. Camillo-Forlanini

    Rome, 00151

  • University Campus Bio-Medico

    Rome, 00155

  • Istituto Regina Elena

    Rome, 00161

  • Universita Degli Studi "La Sapeinza"

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • H. San Giovanni-Addolorata Hospital

    Rome, 00184

  • Ospedale di Ronciglione

    Ronciglione, 01037

  • IRCCS "Casa Sollievo della Sofferenza"

    San Giovanni Rotondo, 71013

  • Istituto di Ematologia Universita - University di Sassari

    Sassari, 07100

  • Azienda Ospedale E. Morelli

    Sondalo, 23039

  • Ospedale S. Vincenzo

    Taormina, 98039

  • Ospedal SS Annunziata

    Taranto, 74100

  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

    Turin, 10126

  • Ospedale Giovanni Bosco

    Turin

  • Policlinico Universitario Udine

    Udine, 33100

  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

    Verona

Other trials in Italy

About this study

Official title: Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Conditions
Leukemia
Being tested
asparaginase, daunorubicin hydrochloride, etoposide, idarubicin, imatinib mesylate
Keywords
B-cell adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, TdT positive adult acute lymphoblastic leukemia
Medical subject headings
Leukemia, 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. Percentage of Participants Reaching Disease Free Survival

    Measured: At 60 months

Secondary outcomes (2)

  1. Number of Patients Reaching Complete Hematological Response After Induction Therapy

    Measured: At the end of induction, day +50

  2. Percentage of Participants Reaching Overall Survival

    Overall survival from diagnosis

    Measured: At 60 months

Timeline

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

  1. First posted11 Apr 2007 (estimated)
  2. Study startOct 2004
  3. Primary completionMar 2014
  4. Study completionMar 2014

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
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458848
Sponsor's protocol ID
LAL0904
Other IDs
LAL0904, 2004-001738-11, 2004
Acronym
LAL0904
Status last verified
Sep 2018
First submitted
9 Apr 2007
Last updated
15 Feb 2019
Data monitoring committee
No

Publications

  • Chiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, Falini B, Ronco F, Ferrara F, De Fabritiis P, Luppi M, La Nasa G, Tedeschi A, Califano C, Fanin R, Dore F, Mandelli F, Meloni G, Foa R. A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016 Dec;101(12):1544-1552. doi: 10.3324/haematol.2016.144535. Epub 2016 Aug 11.

    PubMed 27515250

  • 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

  • Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.

    PubMed 34048072

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing asparaginase, daunorubicin hydrochloride and etoposide in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 66 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?

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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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 15 Feb 2019). 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?

Percentage of Participants Reaching Disease Free Survival (time frame: At 60 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 NCT00458848, which also lists 3 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 15 Feb 2019.

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LAL0904 Clinical Trial NCT00458848 | AzTrials