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

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ClinicalTrials.gov Identifier: NCT00376467
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Imatinib Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2001
Actual Primary Completion Date : June 2010
Actual Study Completion Date : February 2011

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. for Study A, the primary endpoint for activity is overall CMR rate [ Time Frame: after 6 months of imatinib treatment ]
  2. for Study B, the primary endpoint for activity is overall CHR (+/- CMR) rate . [ Time Frame: after induction treatment ]

Secondary Outcome Measures :
  1. complete hematological or molecular remission duration [ Time Frame: at study end ]
  2. overall survival. [ Time Frame: at study end ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376467


Locations
Italy
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
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
Palermo, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Ematologia - Ospedale San Carlo
Potenza, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
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
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
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
Investigators
Principal Investigator: Michele Baccarani Università degli Studi di Udine
More Information
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Publications of Results:

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00376467     History of Changes
Other Study ID Numbers: LAL0201
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action