Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
NCT ID: NCT00458848
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
470 participants
INTERVENTIONAL
2004-10-31
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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asparaginase
daunorubicin hydrochloride
etoposide
idarubicin
imatinib mesylate
mercaptopurine
methotrexate
methylprednisolone
mitoxantrone hydrochloride
prednisone
vincristine sulfate
allogeneic hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
60 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Roberto Foa, MD
Role: STUDY_CHAIR
Universita Degli Studi "La Sapeinza"
Locations
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Ospedale Civile Alessandria
Alessandria, , Italy
Ospedale Torrette University Ancona
Ancona, , Italy
Ospedale S. Donato
Arezzo, , Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno, , Italy
S.G. Moscati Hospital
Avellino, , Italy
Universita Degli Studi di Bari
Bari, , Italy
University of Bologna Medical School
Bologna, , Italy
Spedali Civili di Brescia
Brescia, , Italy
A. Perrino Hospital
Brindisi, , Italy
Ospedale Binaghi
Cagliari, , Italy
Ospedale Ferrarotto
Catania, , Italy
Ospedale Regionale A. Pugliese
Catanzaro, , Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Cosenza, , Italy
Universita di Ferrara
Ferrara, , Italy
Azienda Ospedaliera di Firenze
Florence, , Italy
Ospedali Riuniti Foggia
Foggia, , Italy
Ospedale Umberto I
Frosinone, , Italy
Ospedale S. Antonio Abate
Gallarate, , Italy
Ospedale San Martino
Genoa, , Italy
Ospedale Santa Maria Goretti
Latina, , Italy
Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, , Italy
Ospedale Maggiore Lodi
Lodi, , Italy
Ospedale L'Aquila
L’Aquila, , Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino
Messina, , Italy
Ospedale Niguarda Ca'Granda
Milan, , Italy
Azienda Ospedaliera - Universitaria di Modena
Modena, , Italy
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
Naples, , Italy
Federico II University Medical School
Naples, , Italy
Ospedale S. Gennaro ASL NA1
Naples, , Italy
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
Nocera Inferiore, , Italy
Amedeo Avogadro University of Eastern Piedmont
Novara, , Italy
Ospedale San Francesco
Nuoro, , Italy
Azienda Ospedale S. Luigi at University of Torino
Orbassano, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Policlinico - Cattedra di Ematologia
Palermo, , Italy
Ospedale Cervello
Palermo, , Italy
Ospedale La Maddalena - Palermo
Palermo, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
University of Pavia
Pavia, , Italy
Perugia Regional Cancer Center
Perugia, , Italy
Azienda Ospedale - d S. Salvatore
Pesaro, , Italy
Ospedale Civile Pescara
Pescara, , Italy
Azienda Ospedaliera Pisana
Pisa, , Italy
Azienda Ospedaliera San Carlo - Potenza
Potenza, , Italy
Ospedale Sta. Maria Delle Croci
Ravenna, , Italy
Ospedale S. M. delle Croci
Ravenna, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Ospedale Oncologico Regionale
Rionero in Vulture, , Italy
Ospedale Sant' Eugenio
Rome, , Italy
Azienda Ospedaliera S. Camillo-Forlanini
Rome, , Italy
University Campus Bio-Medico
Rome, , Italy
Istituto Regina Elena
Rome, , Italy
Universita Degli Studi "La Sapeinza"
Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , Italy
H. San Giovanni-Addolorata Hospital
Rome, , Italy
Ospedale di Ronciglione
Ronciglione, , Italy
IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, , Italy
Istituto di Ematologia Universita - University di Sassari
Sassari, , Italy
Azienda Ospedale E. Morelli
Sondalo, , Italy
Ospedale S. Vincenzo
Taormina, , Italy
Ospedal SS Annunziata
Taranto, , Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, , Italy
Ospedale Giovanni Bosco
Turin, , Italy
Policlinico Universitario Udine
Udine, , Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, , Italy
Countries
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References
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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.
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.
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.
Related Links
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GIMEMA Foundation Website
Other Identifiers
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LAL0904
Identifier Type: OTHER
Identifier Source: secondary_id
2004-001738-11
Identifier Type: OTHER
Identifier Source: secondary_id
LAL0904
Identifier Type: -
Identifier Source: org_study_id
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