acute lymphoblastic leukemia infant acute lymphoblastic leukemia
Conditions
Interventions
Phase 1 Induction
The first five weeks of your child's treatment are called Induction. In this phase a combination of drugs is given with the aim to destroy as many leukemia cells as possible. How int
Sponsors
Miyamura Takako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed B- precursor ALL or B-cell MPAL according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement. 2. -<365 days of age at the time of diagnosis of ALL. 3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Exclusion criteria
Exclusion criteria: 1. KMT2A-wildtype patients. 2. Multilineage MPAL 3. T-ALL. 4. Age > 365 days at the time of diagnosis. 5. Down syndrome. 6. Relapsed ALL. 7. Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study. Additional exclusion criteria for blinatumomab: 1. CD19 negative B-precursor ALL at diagnosis 2. CNS involvement (CNS2/CNS3 status) at the EOI. Patients with CNS disease at the time of diagnosis are eligible if CNS1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of induction). 3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab. 4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to B-cell recovery after the last dose of blinatumomab. If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2A-rearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the Interfant-06 protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study objectives 1.To estimate overall survival (OS) and compare it with corresponding historical results of the Interfant-06 protocol, in the whole study and by risk group. 2.To determine outcome (in terms of secondary endpoint 2) according to risk group and compare it with corresponding historical results of the Interfant-06 protocol. 3.To determine outcome (in terms of secondary endpoint 3) taking into account the protocol-specific definition of resistance. 4.To assess the response to different treatment phases in term of minimal residual disease (MRD) response. 5.To evaluate the incidence of CD19 negative relapses 6.To evaluate the incidence of myeloid lineage switches 7.To describe the toxicity associated to each treatment phase 8.To describe long term cardiotoxicity 9.To evaluate survival after relapse, overall and by risk group. Exploratory study objectives 1.Assessment of prognostic factors (e.g. age at diagnosis, white blood cell count at diagnosis (WBC), immunophenotype, type of KMT2A rearrangement, MRD, etc.) 2.To evaluate events after first relapse 3.To evaluate the concordance of MRD assessments by IG-TR PCR and KMT2A PCR, flow cytometry, and Next Generation Sequencing (NGS) (performed in some centers). 4. To determine outcome of patients who meet the blinatumomab exclusion criteria (see section 3.2 of the protocol). The objectives of the sub-studies are detailed in the sub-study protocols. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Norway, Portugal, Republic of Ireland, Saudi Arabia, Slovak Republic, Spain, Sweden, Switzerland
Contacts
Public ContactTakako Miyamura
The University of Osaka Hospital
Outcome results
None listed