Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

Health ProfessionalsPatients

RecruitingLast updated: 11 June 2026

Interfant-21: Immunotherapy given in addition to standard chemotherapy for infants who are diagnosed with KMT2A-rearranged acute lymphoblastic leukaemiaInterfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People0 - 1

Trial acronym

Interfant-21

Clinical summary

Summary

This study is looking at a treatment for infants under 1 year old who have a type of blood cancer called acute lymphoblastic leukaemia (ALL) with a specific high-risk genetic change (KMT2A rearrangement).
 
The aim of the study is to improve outcomes by adding an immunotherapy medicine called blinatumomab to standard treatment.
 
Who is it for?
  • Infants under 1 year old
  • Newly diagnosed with ALL or mixed phenotype acute leukaemia
  • The leukaemia has a high-risk genetic change called KMT2A rearrangement

All eligible infants can take part if their parent or legal guarian provides consent.

 
Study details
All patients begin standard treatment. After the first phase of treatment (induction), all patients receive one cycle of blinatumomab immunotherapy.
 
Treatment after this point depends on both the patient’s risk group and how well the leukaemia responds (measured by minimal residual disease, MRD). Some patients may receive a second cycle of blinatumomab, while others may continue standard treatment or become eligible for a stem cell transplant.

 

Conditions

This trial is treating people with newly diagnosed B-precursor acute lymphoblastic leukaemia (ALL) or B-cell mixed phenotype acute leukaemia (MPAL)

Eligibility

Inclusion

  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

  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.

 

Inclusion

  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Princess Maxima Center for Pediatric Oncology

Scientific Title

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

HelpThis verification step helps prevent fraudulent transactions from automated software.
Submitting ... Please wait