Informations générales (source: ClinicalTrials.gov)
An Observatory for Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL) and Treated With the Combination of Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy. (EWALL_OBS)
Observational
Versailles Hospital (Voir sur ClinicalTrials)
décembre 2012
décembre 2022
29 juin 2024
The use of imatinib in combination 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. Dasatinib is indicated
as first line therapy in Ph+ ALL. Results from the EWALLPH-01 are supporting the use of
dasatinib in combination with low-intensity chemotherapy. A new EWALL-PH-02 study
combining nilotinib in combination with low-intensity chemotherapy is currently initiated
within the EWALL centers.
3. The EWALL-PH-01 trial is now closed after the recruitment of 71 patients. The
activation of the EWALL-PH-02 trial is expected for Q1 2012. Based on the
recruitment of the EWALL-PH-01 study it could be anticipated that 50 to 100 patients
aged more than 55 years will be diagnosed during this 6 months period of time. In
addition, all the EWALL centers are not participating to the EWALL-PH-02 study and
thus these centers could be offered to treat patient following the EWALL backbone in
addition to imatinib. 4. A minimum data set will be defined in order to collect the
data of the patients treated following the EWALL-PH imatinib study. The main
recommendation is to follow as close as possible the procedures of the EWALL-PH-01
trial (mutation analysis, MRD follow-up) in order to have a comparable data set.
This imatinib treated cohort of patients would be of particular importance in order
to better define the potential benefit of using one TKI compared to one other. From
the end of the EWALL-PH-01 study recruitment to the initiation of the EWALL-PH-02
study, patients were treated following the common backbone schedule in combination
with imatinib or others TKI. Patients not included in clinical trials for other
reasons were also offered a treatment with the combination of TKIs and backbone
low-intensity chemotherapy. The goal of this observatory retrospective and
prospective is to describe the efficacy and the tolerance of the combination of
tyrosine kinase inhibitors in combination with low intensity chemotherapy (EWALL
backbone) in patients with Ph+ ALL aged 55 years and over.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | Rousselot Philippe, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Nimes - Nimes - France | JOURDAN Eric | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Male or female patients ≥ 55 years
2. Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
3. Not included in a prospective clinical trial
4. Treatment with the combination of tyrosine kinase inhibitors and low dose
chemotherapy as recommended by the EWALL group (EWALL backbone).
1. Male or female patients ≥ 55 years
2. Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
3. Not included in a prospective clinical trial
4. Treatment with the combination of tyrosine kinase inhibitors and low dose
chemotherapy as recommended by the EWALL group (EWALL backbone).
1. Patients deceded and having previously refused data collection.