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Taking peoplePhase 3

Tests blinatumomab in infants with a genetic type of leukemia

Tests blinatumomab in infants under one year with KMT2A-rearranged acute leukemia.

Key facts

Who runs it
Princess Maxima Center for Pediatric Oncology
Where
Graz, Innsbruck, Salzburg, and Vienna, AustriaSee the 5 sitesAlso in 24 other countries, 163 sites
Registry title
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Status
Recruiting
Phase
Phase 3
People taking part
160 people, planned
Started
15 Dec 2022
Expected to end
Sept 2030
Type of study
Interventional, 2 groups
Treatments tested
  • Blinatumomab
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies up to 365 days old with newly diagnosed B-cell acute lymphoblastic leukemia or B-cell mixed phenotype acute leukemia that has a KMT2A change.

Age
Up to 365 days old at diagnosis (1 day to 1 year).
Sex
Boys and girls can both join.
Disease stage
Newly diagnosed B-precursor ALL or B-cell MPAL (single lineage), by the WHO 2017 classification.
Earlier treatment
No systemic corticosteroids above 10 mg/m2/day for more than one week, and no chemotherapy, in the 4 weeks before diagnosis. Aerosol corticosteroids are allowed.
Biomarker or test result
KMT2A-rearrangement is needed.

Main reasons for not taking part

  • KMT2A-wildtype (no KMT2A change)
  • Multilineage MPAL
  • T-ALL
  • Down syndrome
  • Relapsed ALL

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How old is the patient who may join a trial?
  • What type of cancer has the patient been diagnosed with?
  • Is this cancer newly diagnosed, or has it come back or not responded to treatment?

Where in Austria

Also in 24 other countries, 163 sites

  • Medical University of GrazGraz, AustriaNo longer taking part
  • Medizinische Universitaet InnsbruckInnsbruck, AustriaNo longer taking part
  • Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbHSalzburg, AustriaNo longer taking part
  • St. Anna Childrens Cancer Research Institute GmbHVienna, AustriaNo longer taking part
  • St. Anna Kinderspital GmbHVienna, AustriaNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Medium Risk (MR)Other group

    Subject is defined as MR if \> 6months of age at diagnosis, OR \< 6 months of age with White Blood cell Count (WBC) \< 300 at diagnosis and good prednisone response. Subject gets 1st cycle of blinatumomab. If MRD is \>0.01%, after 1st cycle of blinatumomab, subject will be allocated to HR treatment from that phase, and will be eligible for HSCT. If MRD is undetectable or \< 0.01% after the 1st cycle of blinatumomab (TP2) patient will be eligible for replacement of MARMA by 2nd cycle of blinatumomab after receipt of lymphoid style consolidation (Protocol IB) or of myeloid style consolidation (ADE/MAE).

    Treatment: Blinatumomab

  • High risk (HR)Other group

    Subject is defined as HR if \< 6 months of age with WBC \> 300 at diagnosis OR poor prednisone response. Also MR patients with end of induction MRD ≥ 1%, or MRD \> 0.01% after the 1st cycle of blinatumomab, will be allocated to HR treatment. Subject gets 1 cycle of blinatumomab. Thereafter patient is eligible for hematopoietic stem cell transplantation (HSCT) with or without experimental therapy in an investigational window.

    Treatment: Blinatumomab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Plain-language title
Tests blinatumomab in infants with a genetic type of leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05327894, who can take part
Publications
Record updated
19 October 2026