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Treatment of infants under one year with acute lymphoblastic leukemia according to the Interfant-21 protocol
EU CTIS ID: 2022-502503-30-00
What this study is testing
To improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2Arearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the Interfant06 protocol.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement.
- ≤ 365 days of age at the time of diagnosis of ALL.
- Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
You likely can't join if
- KMT2A-wildtype patients.
- Down syndrome
- Multilineage MPAL
- 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.
- T-ALL.
- Age > 365 days at the time of diagnosis.
See the full eligibility criteria
- Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement.
- ≤ 365 days of age at the time of diagnosis of ALL.
- Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
- KMT2A-wildtype patients.
- Down syndrome
- Multilineage MPAL
- 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.
- T-ALL.
- Age > 365 days at the time of diagnosis.
- Relapsed ALL.
- Additional exclusion criteria for blinatumomab: 1. CD19 negative B-precursor ALL at diagnosis
- Additional exclusion criteria for blinatumomab: 2. CNS involvement (CNS2/CNS3/TLP+ 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).
- Additional exclusion criteria for blinatumomab: 3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.
- Additional exclusion criteria for blinatumomab: 4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to Bcell recovery after the last dose of blinatumomab.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Saudi Arabia
- Japan
- Switzerland
- Chile
- Australia
- Israel
- Argentina
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Saudi Arabia; Japan; Switzerland; Chile; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.