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)
2 other identifiers
interventional
79
3 countries
69
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
Longer than P75 for phase_2
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedJuly 30, 2020
July 1, 2020
8.2 years
February 3, 2012
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of efficacy of a nilotinib-based induction and consolidation therapy
rate of patients without event
after 12 months
Secondary Outcomes (13)
complete haematological remission
after induction treatment (week 5)
major molecular response in bone marrow
complete molecular response
undetectable BCR-ABL level
Event free survival
- +8 more secondary outcomes
Interventions
Nilotinib, p.o Chemotherapy (Dexamethasone, Methotroxate, Cyclophosphamide (optional), Vincristine, Vindesine, Cytarabine, 6-Mercapto-Purine)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616, France
CHU d'Amiens - Hôpital Sud
Amiens, 80054, France
Chu Angers
Angers, 49933, France
Centre Hospitalier Victor Dupouy
Argenteuil, 95107, France
Centre Hospitalier de la Côte Basque
Bayonne, 64100, France
CHU de Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
CHU de Brest - Hôpital Morvan
Brest, 29609, France
"CHU Cote de nacre "
Caen, 14000, France
CHU Estaing
Clermont-Ferrand, 63003, France
AP-HP - Hôpital Henri Mondor
Créteil, 94010, France
CHRU de Dijon
Dijon, 21079, France
CHU de Grenoble
Grenoble, 38043, France
CH de Versailles - Hôpital André Mignot
Le Chesnay, 78157, France
Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent
Lille, 59020, France
CHRU de Lille
Lille, 59037, France
C H U de Limoges - Hôpital Dupuytren
Limoges, 87042, France
Institut Paoli-Calmettes
Marseille, 13273, France
CH de Meaux
Meaux, 77104, France
Hôpital Saint-Eloi
Montpellier, 34295, France
CH de Mulhouse - Hôpital Emile Muller
Mulhouse, 68070, France
CHU Hôtel Dieu, Nantes
Nantes, 44000, France
CHU de Nice - Hôpital l'Archet 1
Nice, 06200, France
CHR d'Orléans - Hôpital La Source
Orléans, 45032, France
AP-HP - Hôpital Saint Louis
Paris, 75010, France
AP-HP - Hôpital SAINT-ANTOINE
Paris, 75571, France
AP-HP - Hôpital Necker
Paris, 75743, France
CH de Perpignan - Hôpital Saint-Jean
Perpignan, 66046, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers - Hôpital La Milétrie
Poitiers, 86021, France
CH de la Région d'Annecy
Pringy, 74374, France
CHU de Reims - Hôpital Robert Debré
Reims, 51092, France
CHU de Rennes, Hôpital Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel, Rouen
Rouen, 76038, France
CHU de La Réunion - Hôpital Félix Guyon
Saint-Denis, 97405, France
CHRU de Strasbourg - Hôpital Hautepierre
Strasbourg, 67098, France
HIA Sainte Anne
Toulon, 83041, France
"Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)"
Toulouse, 31100, France
CHRU de Tours - Hôpital Bretonneau
Tours, 37044, France
Centre Hospitalier de Valenciennes
Valenciennes, 59322, France
CHU de Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, 54511, France
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, 70376, Germany
Klinikum der Universität Regensburg
Regensburg, Bavaria, 93042, Germany
University Hospital of Frankfurt, Medical Dept. II
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Universitätsklinik Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinik Dresden
Dresden, Saxony, 01307, Germany
Uniklinik Aachen
Aachen, 52074, Germany
Charité Universitätsmedizin Berlin
Berlin, 13353, Germany
University Hospital Düsseldorf
Düsseldorf, 40225, Germany
Universitätsklinikum Göttingen
Göttingen, 37075, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24116, Germany
Universität Leipzig, José-Carreras-Haus
Leipzig, 04103, Germany
Universitätskliniken Mainz
Mainz, 55101, Germany
Klinikum Mannheim
Mannheim, 68167, Germany
Universitätsklinikum Großhadern
München, 81377, Germany
Klinikum Nürnberg Nord
Nuremberg, 90419, Germany
Klinikum Oldenburg
Oldenburg, 26133, Germany
Universität Rostock
Rostock, 18055, Germany
Medizinische Universitätsklinik Ulm
Ulm, 89070, Germany
Universität Würzburg
Würzburg, 97080, Germany
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Germans Trias i Pujol (ICO - Badalona)
Barcelona, 08916, Spain
Hospital Universitario 12 de Octubre (Madrid)
Madrid, 28041, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocío (Sevilla)
Seville, 41013, Spain
Hospital Universitario y Politécnico La Fe (Valencia)
Valencia, 46026, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heike Pfeifer, Dr.med.
Johann Wolfgang Goethe University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med.
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 7, 2012
Study Start
January 1, 2012
Primary Completion
March 10, 2020
Study Completion
March 10, 2020
Last Updated
July 30, 2020
Record last verified: 2020-07