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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00376467
First received: September 13, 2006
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
zienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, 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
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
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
Roma, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
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

Additional Information:
Publications:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov 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
Adult
Elderly
Imatinib

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

ClinicalTrials.gov processed this record on October 29, 2014