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Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

RecruitingPhase 3Ages 1 Day - 1 YearAllPrincess Maxima Center for Pediatric Oncology
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In plain words

What the trial is, and whether it could suit you

This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. ≤ 365 days of age at the time of diagnosis of ALL. 3. Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations. Exclusion criteria for blinatumomab: 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. If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
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What it tests

  • Blinatumomab
  • Blinatumomab
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Where

124 sites
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"
Buenos Aires, Argentina
Australian and New Zealand Children's Haematology/Oncology Group
Clayton, Australia
North Adelaide- Womens and Childrens Hospital
Adelaide, Australia
Monash Children's Hosptial
Clayton, Australia
New Lambton Heights- John Hunter Children's Hospital
New Lambton Heights, Australia
Royal Children's Hospital (Children's Cancer Centre)
Parkville, Australia
Perth Children's Hospital
Perth, Australia
Queensland Children's Hospital
South Brisbane, Australia

…and 116 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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