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Philadelphia Chromsome Positive Acute Lymphoblastic LeukemiaPhase 2NCT01528085

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

A Phase 2 study testing Nilotinib in people with Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia, run by Goethe University at 69 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Nilotinib
How many people
79 participants
Where
69 sitesin 3 countries
Study dates
Jan 2012to 10 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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
Show all 33Show fewer
  • 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.

Trial locations and contacts

69 sites in 3 countries.

69 sites in 3 countries

France41 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13616

  • CHU d'Amiens - Hôpital Sud

    Amiens, 80054

  • Chu Angers

    Angers, 49933

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • CHU de Brest - Hôpital Morvan

    Brest, 29609

  • "CHU Cote de nacre "

    Caen, 14000

  • CHU Estaing

    Clermont-Ferrand, 63003

  • AP-HP - Hôpital Henri Mondor

    Créteil, 94010

  • CHRU de Dijon

    Dijon, 21079

  • CHU de Grenoble

    Grenoble, 38043

  • CH de Versailles - Hôpital André Mignot

    Le Chesnay, 78157

  • Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent

    Lille, 59020

  • CHRU de Lille

    Lille, 59037

  • C H U de Limoges - Hôpital Dupuytren

    Limoges, 87042

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CH de Meaux

    Meaux, 77104

  • Hôpital Saint-Eloi

    Montpellier, 34295

  • CH de Mulhouse - Hôpital Emile Muller

    Mulhouse, 68070

  • CHU Hôtel Dieu, Nantes

    Nantes, 44000

  • CHU de Nice - Hôpital l'Archet 1

    Nice, 06200

  • CHR d'Orléans - Hôpital La Source

    Orléans, 45032

  • AP-HP - Hôpital Saint Louis

    Paris, 75010

  • AP-HP - Hôpital SAINT-ANTOINE

    Paris, 75571

  • AP-HP - Hôpital Necker

    Paris, 75743

  • CH de Perpignan - Hôpital Saint-Jean

    Perpignan, 66046

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers - Hôpital La Milétrie

    Poitiers, 86021

  • CH de la Région d'Annecy

    Pringy, 74374

  • CHU de Reims - Hôpital Robert Debré

    Reims, 51092

  • CHU de Rennes, Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel, Rouen

    Rouen, 76038

  • CHU de La Réunion - Hôpital Félix Guyon

    Saint-Denis, 97405

  • CHRU de Strasbourg - Hôpital Hautepierre

    Strasbourg, 67098

  • HIA Sainte Anne

    Toulon, 83041

  • "Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)"

    Toulouse, 31100

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37044

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59322

  • CHU de Nancy - Hôpital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany22 sites

  • Uniklinik Aachen

    Aachen, 52074

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Universitätsklinik Dresden

    Dresden, Saxony, 01307

  • University Hospital Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • University Hospital of Frankfurt, Medical Dept. II

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24116

  • Universität Leipzig, José-Carreras-Haus

    Leipzig, 04103

  • Universitätskliniken Mainz

    Mainz, 55101

  • Klinikum Mannheim

    Mannheim, 68167

  • Universitätsklinikum Großhadern

    München, 81377

  • Universitätsklinik Münster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Klinikum der Universität Regensburg

    Regensburg, Bavaria, 93042

  • Universität Rostock

    Rostock, 18055

  • Robert Bosch Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

  • Medizinische Universitätsklinik Ulm

    Ulm, 89070

  • Universität Würzburg

    Würzburg, 97080

Other trials in Germany

Spain6 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Germans Trias i Pujol (ICO - Badalona)

    Barcelona, 08916

  • Hospital Universitario 12 de Octubre (Madrid)

    Madrid, 28041

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocío (Sevilla)

    Seville, 41013

  • Hospital Universitario y Politécnico La Fe (Valencia)

    Valencia, 46026

Other trials in Spain

About this study

Official title: 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.

Being tested
Nilotinib
Keywords
Philadelphia chromsome, BCR-ABL, ALL, acute lymphoblastic leukemia, Nilotinib, Tasigna
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NilotinibDrug

    Also called Tasigna

    Nilotinib, p.o Chemotherapy (Dexamethasone, Methotroxate, Cyclophosphamide (optional), Vincristine, Vindesine, Cytarabine, 6-Mercapto-Purine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of efficacy of a nilotinib-based induction and consolidation therapy

    rate of patients without event

    Measured: after 12 months

Secondary outcomes (13)

  1. complete haematological remission

    The rate of complete haematological remission after induction treatment

    Measured: after induction treatment (week 5)

  2. major molecular response in bone marrow

    major molecular response defined by a BCR-ABL/ABL < 0.1% in bone marrow

  3. complete molecular response

    complete molecular response defined by a BCR-ABL/ABL < 0.001% in bone marrow

  4. undetectable BCR-ABL level

    The proportion of patients with confirmed undetectable BCR-ABL level with a test sensitivity of at least 4.5 log.

  5. Event free survival

  6. Relapse free survival

  7. Progression free survival

  8. T315I or p-loop Mutations

    Detection of a T315I or p-loop BCR-ABL TK domain mutation

  9. molecular relapse or progression

    The proportion of patients with molecular relapse or progression

  10. Overall survival

  11. Tolerability

    Tolerability as determined by descriptive assessment of adverse events and discontinuation due to treatment-related SAEs

  12. Death during induction

    (all patients who started treatment)

    Measured: End of induction (week 5)

  13. Death in complete remission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completion10 Mar 2020
  4. Study completion10 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528085
Sponsor's protocol ID
EWALL-PH-02
Other IDs
2010-022855-46
Status last verified
Jul 2020
First submitted
3 Feb 2012
Last updated
30 Jul 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nilotinib in people with Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia, run by Goethe University at 69 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in France, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of efficacy of a nilotinib-based induction and consolidation therapy (time frame: after 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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