- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01528085
Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
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)
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Barcelona, Espanja, 08036
- Hospital Clínic de Barcelona
-
Barcelona, Espanja, 08916
- Hospital Universitario Germans Trias i Pujol (ICO - Badalona)
-
Madrid, Espanja, 28041
- Hospital Universitario 12 de Octubre (Madrid)
-
Salamanca, Espanja, 37007
- Hospital Clinico Universitario de Salamanca
-
Sevilla, Espanja, 41013
- Hospital Universitario Virgen del Rocío (Sevilla)
-
Valencia, Espanja, 46026
- Hospital Universitario y Politécnico La Fe (Valencia)
-
-
-
-
-
AMIENS Cedex 1, Ranska, 80054
- Chu D'Amiens - Hopital Sud
-
ANGERS Cedex 09, Ranska, 49933
- CHU Angers
-
Aix-en-Provence cedex 1, Ranska, 13616
- Centre Hospitalier du Pays d'Aix
-
Argenteuil Cedex, Ranska, 95107
- Centre Hospitalier Victor Dupouy
-
BESANÇON Cedex, Ranska, 25030
- CHU de Besançon - Hôpital Jean Minjoz
-
BREST Cedex, Ranska, 29609
- Chu de Brest - Hôpital Morvan
-
Bayonne, Ranska, 64100
- Centre Hospitalier de la Côte Basque
-
Caen, Ranska, 14000
- "CHU Cote de nacre "
-
Clermont Ferrand, Ranska, 63003
- CHU Estaing
-
Creteil, Ranska, 94010
- AP-HP - Hôpital Henri Mondor
-
DIJON Cedex, Ranska, 21079
- CHRU de Dijon
-
Grenoble cedex 9, Ranska, 38043
- CHU de Grenoble
-
LE CHESNAY Cedex, Ranska, 78157
- CH de Versailles - Hôpital André Mignot
-
LILLE Cedex, Ranska, 59037
- CHRU de Lille
-
LIMOGES Cedex, Ranska, 87042
- C H U de Limoges - Hôpital Dupuytren
-
Lille Cedex, Ranska, 59020
- Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent
-
MEAUX Cedex, Ranska, 77104
- CH de Meaux
-
MONTPELLIER Cedex 5, Ranska, 34295
- Hôpital Saint-Eloi
-
MULHOUSE Cedex, Ranska, 68070
- CH de Mulhouse - Hôpital Emile Muller
-
Marseille cedex 9, Ranska, 13273
- Institut Paoli-Calmettes
-
Nantes, Ranska, 44000
- CHU Hôtel Dieu, Nantes
-
Nice, Ranska, 06200
- CHU de Nice - Hôpital l'Archet 1
-
ORLEANS Cedex, Ranska, 45032
- CHR d'Orléans - Hôpital La Source
-
PARIS Cedex 10, Ranska, 75010
- AP-HP - Hôpital Saint Louis
-
PARIS Cedex 15, Ranska, 75743
- AP-HP - Hôpital Necker
-
PARIS cedex 12, Ranska, 75571
- Ap-Hp - Hopital Saint-Antoine
-
PERPIGNAN cedex 09, Ranska, 66046
- CH de Perpignan - Hôpital Saint-Jean
-
PESSAC Cedex, Ranska, 33604
- CHU de Bordeaux - Hopital Haut-Lévêque
-
POITIERS Cedex, Ranska, 86021
- CHU de Poitiers - Hôpital la Milétrie
-
Pierre-Bénite Cedex, Ranska, 69495
- Centre Hospitalier Lyon Sud
-
Pringy Cedex, Ranska, 74374
- CH de la Region d'Annecy
-
REIMS Cedex, Ranska, 51092
- CHU de Reims - Hôpital Robert Debré
-
RENNES Cedex 9, Ranska, 35033
- CHU de Rennes, Hopital Pontchaillou
-
Rouen Cedex 1, Ranska, 76038
- Centre Henri Becquerel, Rouen
-
SAINT DENIS Cedex, Ranska, 97405
- CHU de la Réunion - Hôpital Felix Guyon
-
STRASBOURG Cedex, Ranska, 67098
- CHRU de Strasbourg - Hôpital Hautepierre
-
TOULON Cedex 9, Ranska, 83041
- HIA Sainte Anne
-
TOURS Cedex 9, Ranska, 37044
- CHRU de Tours - Hôpital Bretonneau
-
Toulouse, Ranska, 31100
- "Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)"
-
VALENCIENNES Cedex, Ranska, 59322
- Centre Hospitalier de Valenciennes
-
Vandoeuvre Les Nancy, Ranska, 54511
- CHU de Nancy - Hôpital Brabois
-
-
-
-
-
Aachen, Saksa, 52074
- Uniklinik Aachen
-
Berlin, Saksa, 13353
- Charité Universitätsmedizin Berlin
-
Düsseldorf, Saksa, 40225
- University Hospital Düsseldorf
-
Göttingen, Saksa, 37075
- Universitätsklinikum Göttingen
-
Hamburg, Saksa, 20099
- Asklepios Klinik St. Georg
-
Kiel, Saksa, 24116
- Universitätsklinikum Schleswig-Holstein Campus Kiel
-
Leipzig, Saksa, 04103
- Universität Leipzig, José-Carreras-Haus
-
Mainz, Saksa, 55101
- Universitätskliniken Mainz
-
Mannheim, Saksa, 68167
- Klinikum Mannheim
-
München, Saksa, 81377
- Universitätsklinikum Großhadern
-
Nürnberg, Saksa, 90419
- Klinikum Nürnberg Nord
-
Oldenburg, Saksa, 26133
- Klinikum Oldenburg
-
Rostock, Saksa, 18055
- Universität Rostock
-
Ulm, Saksa, 89070
- Medizinische Universitätsklinik Ulm
-
Würzburg, Saksa, 97080
- Universität Würzburg
-
-
Baden-Württemberg
-
Stuttgart, Baden-Württemberg, Saksa, 70376
- Robert Bosch Krankenhaus
-
-
Bayern
-
Regensburg, Bayern, Saksa, 93042
- Klinikum der Universität Regensburg
-
-
Hessen
-
Frankfurt, Hessen, Saksa, 60590
- University Hospital of Frankfurt, Medical Dept. II
-
-
NRW
-
Essen, NRW, Saksa, 45147
- Universitätsklinikum Essen
-
Münster, NRW, Saksa, 48149
- Universitätsklinik Münster
-
-
Niedersachsen
-
Hannover, Niedersachsen, Saksa, 30625
- Medizinische Hochschule Hannover
-
-
Sachsen
-
Dresden, Sachsen, Saksa, 01307
- Universitatsklinik Dresden
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Male or female patients > 55 years
- Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia
- Not previously treated except with corticosteroids or single dose vincristine (three doses cyclophosphamide accepted)
- With or without documented CNS involvement
- WHO performance status < 2
- 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
- Signed written inform consent
- Molecular evaluation for BCR-ABL performed
- 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:
- Patient previously treated with tyrosine kinase inhibitors
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)
- 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.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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Evaluation of efficacy of a nilotinib-based induction and consolidation therapy
Aikaikkuna: after 12 months
|
rate of patients without event
|
after 12 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Kokonaisselviytyminen
|
||
Etenemisvapaa selviytyminen
|
||
Tapahtumaton selviytyminen
|
||
Relapse-vapaa selviytyminen
|
||
complete haematological remission
Aikaikkuna: 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
Aikaikkuna: End of induction (week 5)
|
(all patients who started treatment)
|
End of induction (week 5)
|
Death in complete remission
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Heike Pfeifer, Dr.med., Johann Wolfgang Goethe University Hospital
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Neoplasmat
- Lymfoproliferatiiviset häiriöt
- Lymfaattiset sairaudet
- Immunoproliferatiiviset häiriöt
- Kromosomipoikkeamat
- Translokaatio, geneettinen
- Leukemia
- Prekursorisolulymfoblastinen leukemia-lymfooma
- Leukemia, imusolmukkeet
- Philadelphian kromosomi
Muut tutkimustunnusnumerot
- EWALL-PH-02
- 2010-022855-46 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Nilotinib
-
KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals...Ei vielä rekrytointia
-
Novartis PharmaceuticalsValmis
-
Georgetown UniversityNational Institutes of Health (NIH)RekrytointiDementia Lewyn ruumiillaYhdysvallat
-
Georgetown UniversityTuntematon
-
Technical University of MunichValmisAkuutti myelooinen leukemiaSaksa
-
University Hospital, LilleNovartisValmisGraft versus Host -tautiRanska, Belgia
-
Georgetown UniversityTuntematonParkinsonin tauti | Parkinsonin tauti ja dementiaYhdysvallat
-
The First Affiliated Hospital of Soochow UniversityRekrytointiCML, krooninen vaihe; TKIKiina
-
Hamad Medical CorporationLopetettuKrooninen myelooinen leukemia - krooninen vaiheQatar
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiKrooninen vaihe Krooninen myelooinen leukemia, BCR-ABL1 positiivinenYhdysvallat