RecruitingPhase 3

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

Argentina, Australia160 participantsStarted 2022-12-15

Plain-language summary

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.

Who can participate

Age range1 Day – 1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion criteria

✕. KMT2A-wildtype patients.
✕. Multilineage MPAL
✕. T-ALL.
✕. Age \> 365 days at the time of diagnosis.
✕. Down syndrome.
✕. Relapsed ALL.
✕. 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.

What they're measuring

Event free survival (EFS).

Timeframe: 5 years

Trial details

NCT IDNCT05327894

SponsorPrincess Maxima Center for Pediatric Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Lieke van den Wildenberg

0031 88 972 72 72 trialmanagement@prinsesmaximacentrum.nl

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials