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Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

29 luglio 2020 aggiornato da: Heike Pfeifer MD, Goethe University

An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)

The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

79

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • AMIENS Cedex 1, Francia, 80054
        • Chu D'Amiens - Hopital Sud
      • ANGERS Cedex 09, Francia, 49933
        • CHU Angers
      • Aix-en-Provence cedex 1, Francia, 13616
        • Centre Hospitalier du Pays d'Aix
      • Argenteuil Cedex, Francia, 95107
        • Centre Hospitalier Victor Dupouy
      • BESANÇON Cedex, Francia, 25030
        • CHU de Besançon - Hôpital Jean Minjoz
      • BREST Cedex, Francia, 29609
        • Chu de Brest - Hôpital Morvan
      • Bayonne, Francia, 64100
        • Centre Hospitalier de la Côte Basque
      • Caen, Francia, 14000
        • "CHU Cote de nacre "
      • Clermont Ferrand, Francia, 63003
        • CHU Estaing
      • Creteil, Francia, 94010
        • AP-HP - Hôpital Henri Mondor
      • DIJON Cedex, Francia, 21079
        • CHRU de Dijon
      • Grenoble cedex 9, Francia, 38043
        • CHU de Grenoble
      • LE CHESNAY Cedex, Francia, 78157
        • CH de Versailles - Hôpital André Mignot
      • LILLE Cedex, Francia, 59037
        • CHRU de Lille
      • LIMOGES Cedex, Francia, 87042
        • C H U de Limoges - Hôpital Dupuytren
      • Lille Cedex, Francia, 59020
        • Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent
      • MEAUX Cedex, Francia, 77104
        • CH de Meaux
      • MONTPELLIER Cedex 5, Francia, 34295
        • Hôpital Saint-Eloi
      • MULHOUSE Cedex, Francia, 68070
        • CH de Mulhouse - Hôpital Emile Muller
      • Marseille cedex 9, Francia, 13273
        • Institut Paoli-Calmettes
      • Nantes, Francia, 44000
        • CHU Hôtel Dieu, Nantes
      • Nice, Francia, 06200
        • CHU de Nice - Hôpital l'Archet 1
      • ORLEANS Cedex, Francia, 45032
        • CHR d'Orléans - Hôpital La Source
      • PARIS Cedex 10, Francia, 75010
        • AP-HP - Hôpital Saint Louis
      • PARIS Cedex 15, Francia, 75743
        • AP-HP - Hôpital Necker
      • PARIS cedex 12, Francia, 75571
        • Ap-Hp - Hopital Saint-Antoine
      • PERPIGNAN cedex 09, Francia, 66046
        • CH de Perpignan - Hôpital Saint-Jean
      • PESSAC Cedex, Francia, 33604
        • CHU de Bordeaux - Hopital Haut-Lévêque
      • POITIERS Cedex, Francia, 86021
        • CHU de Poitiers - Hôpital la Milétrie
      • Pierre-Bénite Cedex, Francia, 69495
        • Centre Hospitalier Lyon Sud
      • Pringy Cedex, Francia, 74374
        • CH de la Region d'Annecy
      • REIMS Cedex, Francia, 51092
        • CHU de Reims - Hôpital Robert Debré
      • RENNES Cedex 9, Francia, 35033
        • CHU de Rennes, Hopital Pontchaillou
      • Rouen Cedex 1, Francia, 76038
        • Centre Henri Becquerel, Rouen
      • SAINT DENIS Cedex, Francia, 97405
        • CHU de la Réunion - Hôpital Felix Guyon
      • STRASBOURG Cedex, Francia, 67098
        • CHRU de Strasbourg - Hôpital Hautepierre
      • TOULON Cedex 9, Francia, 83041
        • HIA Sainte Anne
      • TOURS Cedex 9, Francia, 37044
        • CHRU de Tours - Hôpital Bretonneau
      • Toulouse, Francia, 31100
        • "Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)"
      • VALENCIENNES Cedex, Francia, 59322
        • Centre Hospitalier de Valenciennes
      • Vandoeuvre Les Nancy, Francia, 54511
        • CHU de Nancy - Hôpital Brabois
  • Germania
      • Aachen, Germania, 52074
        • Uniklinik Aachen
      • Berlin, Germania, 13353
        • Charité Universitätsmedizin Berlin
      • Düsseldorf, Germania, 40225
        • University Hospital Düsseldorf
      • Göttingen, Germania, 37075
        • Universitätsklinikum Göttingen
      • Hamburg, Germania, 20099
        • Asklepios Klinik St. Georg
      • Kiel, Germania, 24116
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Leipzig, Germania, 04103
        • Universität Leipzig, José-Carreras-Haus
      • Mainz, Germania, 55101
        • Universitätskliniken Mainz
      • Mannheim, Germania, 68167
        • Klinikum Mannheim
      • München, Germania, 81377
        • Universitätsklinikum Großhadern
      • Nürnberg, Germania, 90419
        • Klinikum Nürnberg Nord
      • Oldenburg, Germania, 26133
        • Klinikum Oldenburg
      • Rostock, Germania, 18055
        • Universität Rostock
      • Ulm, Germania, 89070
        • Medizinische Universitätsklinik Ulm
      • Würzburg, Germania, 97080
        • Universität Würzburg
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germania, 70376
        • Robert Bosch Krankenhaus
    • Bayern
      • Regensburg, Bayern, Germania, 93042
        • Klinikum der Universität Regensburg
    • Hessen
      • Frankfurt, Hessen, Germania, 60590
        • University Hospital of Frankfurt, Medical Dept. II
    • NRW
      • Essen, NRW, Germania, 45147
        • Universitätsklinikum Essen
      • Münster, NRW, Germania, 48149
        • Universitätsklinik Münster
    • Niedersachsen
      • Hannover, Niedersachsen, Germania, 30625
        • Medizinische Hochschule Hannover
    • Sachsen
      • Dresden, Sachsen, Germania, 01307
        • Universitatsklinik Dresden
  • Spagna
      • Barcelona, Spagna, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spagna, 08916
        • Hospital Universitario Germans Trias i Pujol (ICO - Badalona)
      • Madrid, Spagna, 28041
        • Hospital Universitario 12 de Octubre (Madrid)
      • Salamanca, Spagna, 37007
        • Hospital Clinico Universitario de Salamanca
      • Sevilla, Spagna, 41013
        • Hospital Universitario Virgen del Rocío (Sevilla)
      • Valencia, Spagna, 46026
        • Hospital Universitario y Politécnico La Fe (Valencia)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

55 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Male or female patients > 55 years
  2. Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia
  3. Not previously treated except with corticosteroids or single dose vincristine (three doses cyclophosphamide accepted)
  4. With or without documented CNS involvement
  5. WHO performance status < 2
  6. Normal serum levels > LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin; or corrected to within normal limits with supplements, prior to the first dose of study medication
  7. Signed written inform consent
  8. Molecular evaluation for BCR-ABL performed
  9. Willingness of male subjects whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of contraception (pearl index < 1%), such as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients during the study and at least 6 months thereafter. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).

Exclusion Criteria:

  1. Patient previously treated with tyrosine kinase inhibitors

  2. Known impaired cardiac function, including any of the following:

    • LVEF < 45%
    • Complete left bundle branch block
    • Right bundle branch block plus left anterior hemiblock, bifascicular block
    • Use of a ventricular-paced pacemaker
    • Congenital long QT syndrome
    • History of or presence of clinically significant ventricular or atrial tachyarrhythmias
    • Clinically significant resting bradycardia (< 50 beats per minute)
    • QTcF>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion.
    • Myocardial infarction with 12 months prior to starting nilotinib
    • Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)
  3. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  4. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or known infection with Hepatitis B or C
  5. Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
  6. Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal or > 5 times ULN if considered due to leukemia
  7. Total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht
  8. Concurrent severe diseases which exclude the administration of therapy
  9. Past history of acute or chronic pancreatits

  10. Patients unwilling or unable to comply with the protocol.e branch block; Right bundle branch block plus left anterior hemiblock, bifascicular block; Use of a ventricular-paced pacemaker; congenital long QT syndrome

    • History of or presence of clinically significant ventricular or atrial tachyarrhythmias
    • Clinically significant resting bradycardia (< 50 beats per minute)
    • QTcF>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion.
    • Myocardial infarction with 12 months prior to starting nilotinib

    • Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)

      • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
      • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or known infection with Hepatitis B or C
      • Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
      • Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal or > 5 times ULN if considered due to leukemia
      • Total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht
      • Concurrent severe diseases which exclude the administration of therapy
      • Past history of acute or chronic pancreatits
      • Patients unwilling or unable to comply with the protocol.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluation of efficacy of a nilotinib-based induction and consolidation therapy
Lasso di tempo: after 12 months
rate of patients without event
after 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sopravvivenza globale
Sopravvivenza libera da progressione
Sopravvivenza senza eventi
Sopravvivenza libera da ricadute
complete haematological remission
Lasso di tempo: after induction treatment (week 5)
The rate of complete haematological remission after induction treatment
after induction treatment (week 5)
major molecular response in bone marrow
major molecular response defined by a BCR-ABL/ABL < 0.1% in bone marrow
complete molecular response
complete molecular response defined by a BCR-ABL/ABL < 0.001% in bone marrow
undetectable BCR-ABL level
The proportion of patients with confirmed undetectable BCR-ABL level with a test sensitivity of at least 4.5 log.
T315I or p-loop Mutations
Detection of a T315I or p-loop BCR-ABL TK domain mutation
molecular relapse or progression
The proportion of patients with molecular relapse or progression
Tolerability
Tolerability as determined by descriptive assessment of adverse events and discontinuation due to treatment-related SAEs
Death during induction
Lasso di tempo: End of induction (week 5)
(all patients who started treatment)
End of induction (week 5)
Death in complete remission

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Goethe University

Investigatori

  • Investigatore principale: Heike Pfeifer, Dr.med., Johann Wolfgang Goethe University Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2012

Completamento primario (Effettivo)

10 marzo 2020

Completamento dello studio (Effettivo)

10 marzo 2020

Date di iscrizione allo studio

Primo inviato

3 febbraio 2012

Primo inviato che soddisfa i criteri di controllo qualità

3 febbraio 2012

Primo Inserito (Stima)

7 febbraio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2020

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EWALL-PH-02
  • 2010-022855-46 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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