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Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study (LAL1408)

This study is currently recruiting participants.
Verified May 2012 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01025505
First received: December 1, 2009
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

This study is an open-label, multicentric, exploratory, single arm, phase II study of adults who are either more than 60 years old, or are unfit for intensive chemotherapy and allo SCT. The patients are treated with NILOTINIB, administered orally twice daily, for 6 weeks (Course A) followed by IMATINIB, administered orally twice daily, for other 6 weeks (Course B).The courses will be repeated (rotated) for a total of 4 times or until relapse, or until it is in the interest of the patients. Prednisone (P) will be administered to all patients for 7-14 days, before TKIs, so as to make it possible to wait for the results of cytogenetic and molecular tests, and to evaluate the response to P alone, hence for another 21 days. Intrathecal therapy (IT) with MTX/AraC/DEX is mandatory, monthly, in patients without clinical-cytologic evidence of meningeal involvement, while in patients with CNS involvement it is performed twice weekly until clearance of leukemic cells, hence once weekly. IM will be administered at the dosage of 600 mg daily (300 mg twice daily) and Nilotinib at the dosage of 800 mg daily (400 mg twice daily) in all courses.

All patients are scheduled to receive at least 4 courses of either drugs, for a total of 4 courses (4 x 6 = 24 weeks). After 4 courses, patients are either allowed to continue the treatment until relapse or progression, if it is in their interest, or to discontinue the treatment and receive other therapies.


Condition Intervention Phase
Treatment
Stem Cell Transplantation
 Drug: Nilotinib
Drug: Imatinib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Front-line Treatment of Ph Positive (Ph+)/Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) With Two Tyrosine Kinase Inhibitors (TKI) (Imatinib and Nilotinib). A Phase II Exploratory Multicentric Study in Elderly Patients and in Patients Unfit for Program of Intensive Therapy and Allogeneic Stem Cell Transplantation. GIMEMA Protocol LAL1408. EudraCT 2009-01327122

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Disease-Free Survival (DFS) [ Time Frame: at 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete Hematological Response (CHR) rate [ Time Frame: at 6, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Complete Cytogenetic Response (CCgR) rate [ Time Frame: at 6, 12 and 24 weeks and duration of CCgR ] [ Designated as safety issue: No ]
  • Complete molecular response rate (CMR) [ Time Frame: at 12 and 24 weeks and duration of CMolR ] [ Designated as safety issue: No ]
  • Type and number of BCR-ABL kinase domain mutations [ Time Frame: developing during and after the study ] [ Designated as safety issue: No ]
  • Relationship between the response, biomarkers and gene expression profile (GEP) [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
  • Event-Free Survival (EFS) and Overall Survival (OS) [ Time Frame: defined as the time from the 1st dose of corticosteroids to death or last contact ] [ Designated as safety issue: No ]
  • Side effects, adverse events (AE) and serious AE (SAE) [ Time Frame: At the end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nilotinib
    The dose of NIL is 800 mg daily (400 mg twice daily). It must be adapted according to specific guidelines in case of adverse events (AE). It cannot be increased.
    Drug: Imatinib
    The dose of IM is 600 mg daily (300 mg b.i.d.). It must be adapted according to specific guidelines in case of AE. It cannot be increased.
  Eligibility

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

Inclusion Criteria:

  • Previously untreated Ph+ ALL more than 60 years old or more than 18 years old, but unfit for program of intensive therapy and allogeneic SCT
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025505

Contacts
Contact: Sandra De Simone, Data Manager +39 0670390521 s.desimone@gimema.it

Locations
Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette" Recruiting
Ancona, Italy
Contact: Massimo OFFIDANI, Pr.            
Contact: Silvia TRAPPOLINI, Dr.            
Principal Investigator: Massimo OFFIDANI, Dr.            
Sub-Investigator: Silvia TRAPPOLINI, Dr.            
Dipartimento Area Medica P.O. Recruiting
Ascoli Piceno, Italy, 63100
Contact: Pietro GALIENI            
Principal Investigator: Piero GALIENI, Dr.            
Sub-Investigator: Catia BIGAZZI, Dr.            
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari Recruiting
Bari, Italy
Contact: Giorgina SPECCHIA, Pr.            
Principal Investigator: Giorgina SPECCHIA, Pr.            
Sub-Investigator: Domenico Pastore, Dr.            
Ospedali Riuniti Recruiting
Bergamo, Italy
Contact: Alessandro RAMBALDI, Pr            
Principal Investigator: Alessandro RAMBALDI, Pr            
Sub-Investigator: Maria Luisa FERRARI, Dr.            
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli Recruiting
Bologna, Italy
Contact: Michele BACCARANI, Pr.         michele.baccarani@unibo.it    
Contact: Giovanni MARTINELLI, Dr.            
Principal Investigator: Michele BACCARANI, Pr.            
Sub-Investigator: Giovanni MARTINELLI, Pr.            
Sezione di Ematologia e Trapianti Spedali Civili Recruiting
Brescia, Italy, 21125
Contact: Domenico RUSSO, Pr.            
Principal Investigator: Domenico RUSSO, Pr.            
Sub-Investigator: Michele MALAGOLA, Dr.            
Osp. Reg. A. Di Summa Recruiting
Brindisi, Italy
Contact: Giovanni QUARTA            
Contact: Antonio ROMANO, Dr.            
Principal Investigator: Giovanni QUARTA, Dr.            
Sub-Investigator: Antonio ROMANO, Dr.            
Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi Recruiting
Cagliari, Italy
Contact: Emanuele ANGELUCCI, Pr.            
Principal Investigator: Emanuele ANGELUCCI, Pr.            
Sub-Investigator: Claudio ROMANI, Dr.            
Ospedale Ferrarotto Recruiting
Catania, Italy, 95124
Contact: Francesco DI RAIMONDO, Pr.            
Contact: Carmela Rita MELI, Dr.            
Principal Investigator: Francesco DI RAIMONDO, Pr.            
Sub-Investigator: Carmela Rita MELI, Dr.            
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna Recruiting
Ferrara, Italy, 44100
Contact: Antonio CUNEO            
Principal Investigator: Antonio CUNEO, Pr.            
Sub-Investigator: Gian Matteo RIGOLIN, Dr.            
Clinica Ematologica - Università degli Studi Recruiting
Genova, Italy
Contact: Angelo Michele CARELLA, Dr            
Contact: G. BELTRANI, Dr.            
Principal Investigator: Angelo Michele CARELLA, Pr.            
Sub-Investigator: Germana BELTRAMI, Dr.            
Ospedale Niguarda "Ca' Granda" Recruiting
Milano, Italy, 20122
Contact: Alessandra TEDESCHI, Dr.         giorgio.lambertenghi@unimi.it    
Principal Investigator: Alessandra TEDESCHI, Dr.            
Sez. di medicina Interna Oncologia ed Ematologia Recruiting
Modena, Italy
Contact: Giuseppe TORELLI            
Principal Investigator: Mario LUPPI, Dr.            
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia Recruiting
Napoli, Italy
Contact: Fabrizio PANE, Pr.            
Principal Investigator: Fabrizio PANE, Pr.            
Ospedale di Rilievo Nazionale "A. Cardarelli" Recruiting
Napoli, Italy
Contact: Felicetto FERRARA, Pr.            
Contact: Salvatore PALMIERI, Dr.            
Principal Investigator: Felicetto FERRARA, Dr.            
Sub-Investigator: Salvatore PALMIERI, Dr.            
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Recruiting
Novara, Italy
Contact: Gianluca GAIDANO, Dr.            
Contact: Monia LUNGHI, Dr.            
Principal Investigator: Gianluca GAIDANO, Dr.            
Sub-Investigator: Monia Lunghi, Dr.            
Ospedale S. Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Contact: Giovanna REGE CAMBRIN, Dr.            
Contact: Carmen FAVA, Dr.            
Principal Investigator: Giovanna REGGE, Dr.            
Sub-Investigator: Carmen FAVA, Dr.            
Università degli Studi di Padova - Ematologia ed Immunologia Clinica Recruiting
Padova, Italy
Contact: Pietro SEMENZATO, Pr.            
Principal Investigator: Pietro SEMENZATO, Dr.            
Sub-Investigator: Gianni BINOTTO, Dr.            
Ospedali Riuniti 'Villa Sofia-Cervello' Recruiting
Palermo, Italy
Contact: Francesco FABBIANO            
Principal Investigator: Francesco Fabbiano, Pr.            
Sub-Investigator: Carla MARINO, Dr.            
Div. di Ematologia IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy, 27100
Contact: Carlo CASTAGNOLA, Dr.            
Contact: Patrizia ZAPPASODI, Dr.            
Principal Investigator: Carlo CASTAGNOLA, Pr.            
Sub-Investigator: Patrizia ZAPPASODI, Dr.            
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore Recruiting
Pesaro, Italy
Contact: Giuseppe VISANI, Pr.            
Principal Investigator: Giuseppe VISANI, Pr.            
Sub-Investigator: Giovanni SPARAVENTI, Dr.            
U.O. Ematologia Clinica - Azienda USL di Pescara Recruiting
Pescara, Italy, 65100
Contact: Giuseppe FIORITONI, Pr.            
Contact: Anna RECCHIA            
Principal Investigator: Giuseppe FIORITONI, Pr.            
Sub-Investigator: Anna RECCHIA, Dr.            
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza Recruiting
Piacenza, Italy
Contact: Daniele VALLISA, Pr.            
Principal Investigator: Daniele VALLISA, Pr.            
Sub-Investigator: Elena TRABACCHI, Dr.            
Ematologia - Ospedale San Carlo Not yet recruiting
Potenza, Italy
Contact: Attilio OLIVIERI, Pr.            
Principal Investigator: Attilio OLIVIERI, Pr.            
Principal Investigator: Angela AMENDOLA, Dr.            
Ospedale S.Maria delle Croci Recruiting
Ravenna, Italy, 48100
Contact: Alfonso ZACCARIA            
Principal Investigator: Alfonso ZACCARIA, Pr.            
Sub-Investigator: Eliana ZUFFA, Dr.            
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Recruiting
Reggio Calabria, Italy
Contact: Francesco NOBILE, Pr.            
Principal Investigator: Francesco NOBILE, Pr.            
Rimini Ospedale "Infermi" Recruiting
Rimini, Italy
Contact: Anna MERLI, Dr.            
Principal Investigator: Anna MERLI, Dr.            
Sub-Investigator: Patrizia TOSI, Dr.            
Università degli Studi - Policlinico di Tor Vergata Not yet recruiting
Roma, Italy, 21100
Contact: Sergio AMADORI         sergio.amadori@ptvonline.it    
Principal Investigator: Sergio AMADORI, Pr.            
Sub-Investigator: Adriano VENDITTI, Pr.            
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Recruiting
Roma, Italy
Contact: Roberto Foà, Pr.            
Principal Investigator: Roberto Foà, Pr.            
Sub-Investigator: Antonella VITALE, Dr.            
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy
Contact: Livio PAGANO, Pr.            
Principal Investigator: Livio PAGANO, Pr.            
Sub-Investigator: Luana FIANCHI, Dr.            
U.O.C. Ematologia - Ospedale S.Eugenio Recruiting
Roma, Italy
Contact: Paolo DE FABRITIIS, Pr.            
Principal Investigator: Paolo DE FABRITIIS, Pr.            
Complesso Ospedaliero S. Giovanni Addolorata Recruiting
Roma, Italy, 00184
Contact: Luciana ANNINO, Pr.            
Contact: Anna CHIERICHINI, Dr.            
Principal Investigator: Luciana ANNINO, Pr.            
Sub-Investigator: Anna CHIERICHINI, Dr.            
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Francesco LAURIA, Pr.            
Principal Investigator: Francesco LAURIA, Pr.            
Sub-Investigator: Monica BOCCHIA, DR.            
SCDO Ematologia 2 AOU S.Giovanni Battista Recruiting
Torino, Italy
Contact: Filippo MARMONT, Dr.            
Principal Investigator: Filippo MARMONT, Dr.            
Sub-Investigator: Ernesta AUDISIO, Dr.            
Azienda USL 9 Treviso - U.O. di Ematologia Not yet recruiting
Treviso, Italy, 31100
Contact: Filippo GHERLINZONI            
Principal Investigator: Filippo GHERLINZONI, Pr.            
Sub-Investigator: Eliana DEGRANDI, Dr.            
Policlinico Universitario - Clinica Ematologia Recruiting
Udine, Italy, 33100
Contact: Anna CANDONI, Dr            
Contact: Erica SIMEONE, Dr.            
Principal Investigator: Anna CANDONI, Dr.            
Sub-Investigator: Erica DIMEONE, Dr.            
Policlinico G.B. Rossi Recruiting
Verona, Italy, 37134
Contact: Giovanni PIZZOLO, Pr.            
Contact: Massimiliano BONIFACIO, Dr.            
Principal Investigator: Giovanni PIZZOLO, Pr.            
Sub-Investigator: Massimiliano BONIFACCIO, Dr.            
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Michele Baccarani Policlinico Sant'Orsola
  More Information

No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01025505     History of Changes
Other Study ID Numbers: LAL1408
Study First Received: December 1, 2009
Last Updated: May 8, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Untreated Ph+ ALL unfit for intense therapy and allo SCT

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

ClinicalTrials.gov processed this record on May 19, 2013