Tyrosine Kinase Inhibitors and Low Intensity Chemotherapy in Ph+ ALL

NCT02888977 | Unknown

• 1 other identifier: 12/13_ EWALL Obs
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• The primary end-point will be Progression Free Survival (PFS) rate at 12 months

  12 months

Secondary Outcomes (10)

• The proportion of Complete haematological remission

  12 months

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

  12 months

• The proportion of Complete molecular response

  12 months

• Event free survival

  12 months

• Relapse free survival

  12 months

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All consecutive previously untreated patients aged 55 years and over with Philadelphia positive acute lymphoblastic leukaemia (Ph+ ALL) not included in a prospective clinical trial and treated with the combination of TKIs and low-intensity chemotherapy (EWALL backbone see Appendix 1) should be recorded in each center.

You may qualify if:

• Male or female patients ≥ 55 years
• Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
• Not included in a prospective clinical trial
• Treatment with the combination of tyrosine kinase inhibitors and low dose chemotherapy as recommended by the EWALL group (EWALL backbone).

You may not qualify if:

• \. Patients deceded and having previously refused data collection.

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (3)

CH Versailles

Le Chesnay, 78150, France

RECRUITING

CHU Nimes

Nîmes, France

RECRUITING

CH Reims

Reims, France

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rousselot philippe, MD

  CH Versailles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morisset Laure

CONTACT

0139239785; lmorisset@ch-versailles.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 5, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)