Treatment of infants under one year with acute lymphoblastic leukemia according to the Interfant-21 protocol
- Conditions
- Acute lymphoblastic leukemiaMedDRA version: 21.0Level: LLTClassification code: 10000845Term: Acute lymphoblastic leukemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502503-30-00
- Lead Sponsor
- Princess Maxima Center For Pediatric Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 205
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., = 365 days of age at the time of diagnosis of ALL., Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
KMT2A-germline patients., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method