Treatment for infants with specific types of leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This treatment protocol involves administering blinatumomab to infants under one year old diagnosed with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia. Eligible infants will receive one cycle of blinatumomab following induction therapy, with further treatment based on their response. Medium risk patients may receive additional cycles or be treated according to standard protocols, while high risk patients may qualify for stem cell transplantation if they achieve minimal residual disease negativity. The study aims to improve treatment outcomes for this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Australian and New Zealand Children's Haematology/Oncology Group
  Clayton, Victoria, Australia Recruiting
• North Adelaide- Womens and Childrens Hospital
  Adelaide, Australia Recruiting
• New Lambton Heights- John Hunter Children's Hospital
  New Lambton Heights, Australia Recruiting
• Perth Children's Hospital
  Perth, Australia Recruiting
• Sydney Childrens Hospital
  Sydney, Australia Recruiting
• The Childrens Hospital at Westmead
  Westmead, Australia Recruiting

+74 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Janine Stutterheim, Dr — Princess Maxima Center for Pediatric Oncology in The Netherlands
• Study coordinator: Lieke van den Wildenberg
• Email: trialmanagement@prinsesmaximacentrum.nl
• Phone: 0031 88 972 72 72

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.