Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy in Ph+ ALL

NCT ID: NCT02888977

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Lymphoblastic Leukemia, Acute

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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).

Exclusion Criteria

1. Patients deceded and having previously refused data collection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Philippe ROUSSELOT

Study coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rousselot philippe, MD

Role: PRINCIPAL_INVESTIGATOR

CH Versailles

Locations

CH Versailles

Le Chesnay, , France

Site Status: RECRUITING

CHU Nimes

Nîmes, , France

Site Status: RECRUITING

CH Reims

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Morisset Laure

Role: CONTACT

lmorisset@ch-versailles.fr

0139239785

Facility Contacts

Rousselot Philippe, MD

Role: primary

JOURDAN Eric

Role: primary

Other Identifiers

12/13_ EWALL Obs

Identifier Type: -

Identifier Source: org_study_id