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Leukemia, Lymphoblastic, AcutePhase 2EWALLPH01NCT02888990

Dasatinib and Low Intensity Chemotherapy for Ph+ Acute Lymphoblastic Leukemia

A Phase 2 study testing Dasatinib in people with Leukemia, Lymphoblastic, Acute, run by Versailles Hospital at 64 sites in 4 countries.

Completed

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

Official record
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Trial summary

1. The use of imatinib in combination or in association with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Leukemia, Lymphoblastic, Acute
What is being tested?
Dasatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
64 sitesin 4 countries
Study dates
Aug 2007to Jan 2016
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 leukaemia
  • Not previously treated except with corticosteroids or single dose vincristine (three doses cyclophosphamide accepted but not recommended)
  • With or without documented CNS involvement
  • Signed written inform consent
  • Molecular evaluation for BCR-ABL done

Who cannot join

  • Patients with ECOG status > 2
  • Patient previously treated with Tyrosine Kinase Inhibitors
  • Patients with QTc > 470 ms
  • Heart insufficiency NYHA grade III/IV, LEVF < 50% and or RF < 30%, myocardial infarction within the past 6 months prior to study
  • Active secondary malignancy
  • Patients with active bacterial, viral or fungal infection
Show all 10Show fewer
  • Known infection with HIV, Hepatitis B (except post vaccinal profile) 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 and total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia
  • Concurrent severe diseases which exclude the administration of therapy

Trial locations and contacts

64 sites in 4 countries.

64 sites in 4 countries

France57 sites

  • Ch D'Aix En Provence

    Aix-en-Provence

  • Groupe Hospitalier Sud

    Amiens

  • CHU Angers

    Angers

  • Chr Annecienne

    Annecy

  • Ch Victor Dupouy

    Argenteuil

  • CHG D'Avignon Henri Duffaut

    Avignon

  • C.H. de la Côte Basque

    Bayonne

  • Hôpital JEAN MINJOZ

    Besançon

  • CH Blois

    Blois

  • Avicenne

    Bobigny

  • CHU Brest

    Brest

  • Hôpital CLEMENCEAU

    Caen

  • HIA Percy

    Clamart

  • Hotel Dieu

    Clermont-Ferrand

  • Hôpital PASTEUR

    Colmar

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • Henry Mondor

    Créteil

  • Hôpital du BOCAGE

    Dijon

  • CH Dunkerque

    Dunkirk

  • Hôpital A. MICHALLON

    Grenoble

  • CH Versailles

    Le Chesnay

  • CH Lens

    Lens

  • Hopital Claude Huriez

    Lille

  • Hôpital Dupuytren

    Limoges

  • Edouard Herriot

    Lyon

  • IPC

    Marseille

  • CH Meaux

    Meaux

  • Hôpital Notre Dame de Bon Secours

    Metz

  • Hôpital LAPEYRONIE

    Montpellier

  • CH E Muller

    Mulhouse

  • Hotel Dieu

    Nantes

  • Archet 1

    Nice

  • CHU Nimes

    Nîmes

  • Hôpital de la Source

    Orléans

  • Cochin

    Paris

  • Hopital St louis

    Paris

  • Necker

    Paris

  • Pitie Salpetrière

    Paris

  • St Antoine

    Paris

  • CH Perpignan

    Perpignan

  • Hôpital du HAUT LEVEQUE

    Pessac

  • Hopital Lyon Sud

    Pierre-Bénite

  • CHU Mileterie

    Poitiers

  • Hopital R Debre

    Reims

  • Hôpital de PONTCHAILLOU

    Rennes

  • CH Victor PROVO

    Roubaix

  • Centre HENRI BECQUEREL

    Rouen

  • centre rene Huguenin

    Saint-Cloud

  • Centre Hospitalier Départemental FELIX GUYON

    Saint-Denis, La Reunion

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • CHU Hautepierre

    Strasbourg

  • HIA Ste Anne

    Toulon

  • Hôpital de PURPAN

    Toulouse

  • CHU Tours

    Tours

  • Hotel Dieu

    Valenciennes

  • CH Brabois

    Vandœuvre-lès-Nancy

  • IGR

    Villejuif

Other trials in France

Italy3 sites

  • Ospedali Riuniti di Bergamo

    Bergamo

  • Ospedale San Gerardo

    Monza

  • Dipartimento Oncologico La Maddalena

    Palermo

Other trials in Italy

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • CHU Ambroise Paré

    Mons

Other trials in Belgium

Germany2 sites

  • St. Johannes-Hospital

    Duisburg

  • Robert Bosch-Krankenhaus

    Stuttgart

Other trials in Germany

About this study

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

  1. The use of imatinib in combination or in association with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over.
  2. However, despite high CR rates, the progression free survival rate at 12 months of patients treated with the combination of imatinib and chemotherapy is 30% to 50%. Relapses remain frequent and only patients intensified with allogenic haematopoietic stem cell transplantation are in long term remission. This strategy is not fully applicable to most patients aged 55 years and over.
  3. Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop. The exact incidence of the T315I mutation is controversial and can be estimated to be near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very strong predictor of relapse.
  4. Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317 mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to imatinib is 33% and the median progression-free survival is 3.7 months. Progression free survival (PFS) rate at 12 months is 22%.

The goal of this trial is to evaluate the efficacy and the tolerance of the combination of dasatinib 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 dasatinib as concomitant therapy during induction and alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a progression free survival of 60% at 12 months are expected. The patients will be prospectively monitored for minimal residual disease and mutation.

Being tested
Dasatinib
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.

Study groups in NCT02888990
Study groupRoleWhat they receive
Treatment ArmExperimentalstandard treatment + dasatinib
Receives: Drug: Dasatinib

What is being measured

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

  1. Progression free survival at 12 months

    Measured: 12 months

Secondary outcomes (12)

  1. The proportion of Complete haematological remission

    Measured: 5 years

  2. The proportion of Major molecular response defined by a BCR-ABL/ABL ≤ 0.1% in bone marrow

    Measured: 5 years

  3. The proportion of Complete molecular response

    Measured: 5 years

  4. Event free survival

    Measured: 5 years

  5. Relapse free survival

    Measured: 5 years

  6. Progression free survival

    Measured: 5 years

  7. The proportion of Detection of a T315I or F317 BCR-ABL TK mutation

    Measured: 5 years

  8. The proportion of Molecular progression

    Measured: 5 years

  9. Overall survival

    Measured: 5 years

  10. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 5 years

  11. Death during induction

    Measured: 2 months

  12. Death in complete remission

    Measured: 5 years

Timeline

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

  1. First posted5 Sep 2016 (estimated)
  2. Study startAug 2007
  3. Primary completionMay 2011
  4. Study completionJan 2016

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
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02888990
Sponsor's protocol ID
2006-005694-21
Acronym
EWALLPH01
Status last verified
Aug 2016
First submitted
19 Aug 2016
Last updated
5 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Leukemia, Lymphoblastic, Acute, run by Versailles Hospital at 64 sites in 4 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 6 inclusion and 10 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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in France, Italy, Belgium, Germany. 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?

Progression free survival at 12 months (time frame: 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 NCT02888990.

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 5 Sep 2016.

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