STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia
1 other identifier
interventional
105
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2001
Longer than P75 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2006
CompletedFirst Posted
Study publicly available on registry
September 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 7, 2014
February 1, 2014
8.5 years
September 13, 2006
February 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
for Study A, the primary endpoint for activity is overall CMR rate
after 6 months of imatinib treatment
for Study B, the primary endpoint for activity is overall CHR (+/- CMR) rate .
after induction treatment
Secondary Outcomes (2)
complete hematological or molecular remission duration
at study end
overall survival.
at study end
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Divisione di Ematologia, Azienda Policlinico "Umberto I", Università degli Studi "La Sapienza"
Rome, Rome, 00161, 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"
Milan, 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
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
Related Publications (1)
Vignetti M, Fazi P, Cimino G, Martinelli G, Di Raimondo F, Ferrara F, Meloni G, Ambrosetti A, Quarta G, Pagano L, Rege-Cambrin G, Elia L, Bertieri R, Annino L, Foa R, Baccarani M, Mandelli F. Imatinib plus steroids induces complete remissions and prolonged survival in elderly Philadelphia chromosome-positive patients with acute lymphoblastic leukemia without additional chemotherapy: results of the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) LAL0201-B protocol. Blood. 2007 May 1;109(9):3676-8. doi: 10.1182/blood-2006-10-052746. Epub 2007 Jan 9.
PMID: 17213285RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Baccarani
Università degli Studi di Udine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2006
First Posted
September 14, 2006
Study Start
December 1, 2001
Primary Completion
June 1, 2010
Study Completion
February 1, 2011
Last Updated
February 7, 2014
Record last verified: 2014-02