Philadelphia chromosome-positive acute lymphoblastic leukemia MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: IMATINIB
Pharmaceutical Form: Capsule
Product Name: CYCLOPHOSPHAMIDE
Pharmaceutical Form: Powder for solution for injection/infusion
Product Name: CYTARABINE
Pharmaceutical Form: Solut
Sponsors
CHU de Rennes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. > 1 year and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known history of chronic myelogenous leukemia (CML). 2. ALL developing after a previous cancer treated with cytotoxic chemotherapy. 3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation 4. Pregnancy 5. Breast Feeding 6. Down syndrome 7. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block 8. Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare disease-free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.;Secondary Objective: 1.To determine the feasibility of administration of imatinib after allogeneic HSCT in High Risk (HR) Ph+ ALL patients. 2. To determine event-free-survival (EFS) of HR pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib. 3. To compare rates of Grade 3 or higher infections in SR Ph+ ALL patients between the two randomized arms. 4. To evaluate EFS and overall survival (OS) of all enrolled participants. 5. To evaluate OS in SR patients. 6. To evaluate OS in HR patients. ;Primary end point(s): To compare disease free survival (DFS) of SR pediatric Ph+ ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone;Timepoint(s) of evaluation of this end point: The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last follow-up for patients without events. DFS comparison will be done according to the intention to treat (ITT) principle by assigned arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To determine the feasibility of administration of imatinib after allogeneic HSCT in HR Ph+ ALL patients 2. To determine event free survival (EFS) of HR pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib 3. To compare rates of Grade 3 or higher infections in Standard Risk Ph+ ALL patients between the two randomized arms 4. To evaluate EFS and overall survival (OS) of all eligible Ph+ ALL patients enrolled on the study 5. To evaluate OS in SR patients 6. To evaluate OS in HR patients ;Timepoint(s) of evaluation of this end point: 1. Description of the toxicities associated with post-HSCT administration of imatinib 2. EFS is defined as the time from the date of bone marrow for MRD assessment at end-IB to first event [resistant disease, relapse, progressive disease, second malignancy, or death in complete remission] or time to last follow-up for patients without events 3. Evaluation of Toxicity and Chemotherapy-related toxicity in Standard Risk Ph+ ALL patients between the two randomized arms 4. Evaluation of EFS and OS will be until the last follow up. 5. OS as secondary endpoint in SR patients is defined as the time from randomization to death from any cause 6. OS in HR patients is defined as time from MRD assessment at end-IB to death from any cause | — |
Countries
France
Contacts
Public ContactValérie Visseiche
CHU de Rennes
Outcome results
None listed