Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy in Ph+ ALL

Lymphoblastic Leukemia, Acute Clinical Trial

— EWALL_OBS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02888977
• Other study ID #: 12/13_ EWALL Obs
• Status: Recruiting
• Start date: December 2012
• Est. completion date: December 2022

Study information

• Verified date: July 2018
• Source: Versailles Hospital
• Contact: Morisset Laure
• Phone: 0139239785
• Email: lmorisset[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
France	CH Versailles	Le Chesnay
France	CHU Nimes	Nimes
France	CH Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point will be Progression Free Survival (PFS) rate at 12 months		12 months
Secondary	The proportion of Complete haematological remission		12 months
Secondary	The proportion of Major molecular response defined by a BCR-ABL/ABL = 0.1% in bone marrow		12 months
Secondary	The proportion of Complete molecular response		12 months
Secondary	Event free survival		12 months
Secondary	Relapse free survival		12 months
Secondary	Progression free survival		12 months
Secondary	The proportion of Detection of a T315I or F317 BCR-ABL TK mutation		12 months
Secondary	The proportion of molecular progression defined by the loss of major molecular response		12 months
Secondary	Overall survival		12 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		12 months