STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia

This study has been completed.
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier:
First received: September 13, 2006
Last updated: February 6, 2014
Last verified: February 2014

This proposal, developed in the framework of the GIMEMA, will permit:

  • to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute lymphoblastic leukemia;
  • to evaluate the molecular response to the treatment, and to monitor the molecular status of remission in all cases achieving or not a molecular response.

The GIMEMA has activated a network to centralize all biological samples (bone marrow and peripheral blood) at diagnosis from all new ALL patients. This will permit to identify, in particular, Ph + and/or BCR/ABL + cases within 5 days from diagnosis, thus permitting to treat these patients according to different programs on the basis of the presence of Ph chromosome.

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: Imatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STI 571 (GLIVEC) in the Treatment of Philadelphia-chromosome Positive and/or BCR/ABL Rearranged Adult Acute Lymphoblastic Leukemia. GIMEMA LAL 0201.

Resource links provided by NLM:

Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • for Study A, the primary endpoint for activity is overall CMR rate [ Time Frame: after 6 months of imatinib treatment ] [ Designated as safety issue: No ]
  • for Study B, the primary endpoint for activity is overall CHR (+/- CMR) rate . [ Time Frame: after induction treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complete hematological or molecular remission duration [ Time Frame: at study end ] [ Designated as safety issue: No ]
  • overall survival. [ Time Frame: at study end ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: December 2001
Study Completion Date: February 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Ph +ve and/or BCR/ABL +ve ALL, either in 1st CHR (independently from the molecular status) for study A, or at diagnosis and untreated for study B;
  • Age >18 years and <60 for study A, >60 for study B;
  • Written voluntary informed consent.

Exclusion Criteria:

  • Patients of childbearing potential without a negative pregnancy test prior to the initiation of study. Barrier contraceptive precautions are to be used throughout the trial in both sexes;
  • Pretreatment with steroids for more than 10 days in study B;
  • Serum bilirubin and creatinine values >3 the upper limit of normal range;
  • SGOT and SGPT values >3 the upper limit of the normal range;
  • Patients who had received any other investigational agent within 4 weeks before the enrollment;
  • Patients with cardiovascular diseases grade >3 according to the New York Heart Association (see Appendix 1);
  • Patients with a history of non compliance to medical regimen or who are considered potentially unreliable;
  • Patients with moderate/severe mood or psychiatric disorders;
  • Concomitant neoplasia.
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Please refer to this study by its identifier: NCT00376467

Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
Az.Ospedaliera S.G.Moscati
Avellino, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
Divisione di Ematologia Ospedale A. Perrino
Brindisi, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Ferrara, Italy
Ospedale Niguarda " Ca Granda"
Milano, Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologi
Modena, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
Napoli, Italy
zienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
Nocera Inferiore, Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
Palermo, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Ematologia - Ospedale San Carlo
Potenza, 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
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, Italy
Divisione di Ematologia, Azienda Policlinico "Umberto I", Università degli Studi "La Sapienza"
Rome, Italy, 00161
Azienda Sanitaria Locale Viterbo - Polo Ospedaliero Centrale - Ospedale Di Ronciglione - U.O. di Ematologia
Ronciglione, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
S. G. Rotondo, Italy
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino, Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Principal Investigator: Michele Baccarani Università degli Studi di Udine
  More Information

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT00376467     History of Changes
Other Study ID Numbers: LAL0201 
Study First Received: September 13, 2006
Last Updated: February 6, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acute Lymphoblastic Leukemia
Philadelphia positive

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on May 26, 2016