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

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ClinicalTrials.gov Identifier: NCT01025505
Recruitment Status : Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Treatment Stem Cell Transplantation Drug: Nilotinib Drug: Imatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 2012
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : May 2018

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U.S. FDA Resources

Arms and Interventions
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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.

Outcome Measures
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Primary Outcome Measures :
  1. Disease-Free Survival (DFS) [ Time Frame: at 24 months ]

Secondary Outcome Measures :
  1. Complete Hematological Response (CHR) rate [ Time Frame: at 6, 12 and 24 weeks ]
  2. Complete Cytogenetic Response (CCgR) rate [ Time Frame: at 6, 12 and 24 weeks and duration of CCgR ]
  3. Complete molecular response rate (CMR) [ Time Frame: at 12 and 24 weeks and duration of CMolR ]
  4. Type and number of BCR-ABL kinase domain mutations [ Time Frame: developing during and after the study ]
  5. Relationship between the response, biomarkers and gene expression profile (GEP) [ Time Frame: At the end of study ]
  6. 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 ]
  7. Side effects, adverse events (AE) and serious AE (SAE) [ Time Frame: At the end of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT01025505


Locations
Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
Dipartimento Area Medica P.O.
Ascoli Piceno, Italy, 63100
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari, Italy
Ospedali Riuniti
Bergamo, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, Italy, 21125
Osp. Reg. A. Di Summa
Brindisi, Italy
Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
Cagliari, Italy
Ospedale Ferrarotto
Catania, Italy, 95124
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, Italy, 44100
Clinica Ematologica - Università degli Studi
Genova, Italy
Ospedale Niguarda "Ca' Granda"
Milano, Italy, 20122
Sez. di medicina Interna Oncologia ed Ematologia
Modena, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
Ospedale di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Ospedale S. Luigi Gonzaga
Orbassano, Italy, 10043
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova, Italy
Ospedali Riuniti 'Villa Sofia-Cervello'
Palermo, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy, 65100
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza, Italy
Ospedale S.Maria delle Croci
Ravenna, Italy, 48100
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Rimini Ospedale "Infermi"
Rimini, Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, Italy, 00184
Università degli Studi - Policlinico di Tor Vergata
Roma, Italy, 21100
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino, Italy
Policlinico Universitario - Clinica Ematologia
Udine, Italy, 33100
Policlinico G.B. Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Michele Baccarani Policlinico Sant'Orsola
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
GIMEMA Foundation website  This link exits the ClinicalTrials.gov site

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01025505     History of Changes
Other Study ID Numbers: LAL1408
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action