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

NCT05327894 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Blinatumomab

1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.

DRUG

Blinatumomab

2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion

Sponsors & Collaborators

  • University of Milano Bicocca

    collaborator OTHER

  • Amgen Europe B.V

    collaborator UNKNOWN

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Principal Investigators

  • Janine Stutterheim, Dr · Princess Maxima Center for Pediatric Oncology in The Netherlands

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2027-09-30
Completion
2030-09-30

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Netherlands
  • New Zealand
  • Norway
  • Portugal
  • Saudi Arabia
  • Slovakia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327894 on ClinicalTrials.gov