NCT05327894 Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
| NCT ID | NCT05327894 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Princess Maxima Center for Pediatric Oncology |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2022-12-15 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Janine Stutterheim, Dr
PRINCIPAL INVESTIGATOR
Princess Maxima Center for Pediatric Oncology in The Netherlands
Frequently Asked Questions
Who can join the NCT05327894 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 1 Year, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05327894 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT05327894 currently recruiting?
Yes, NCT05327894 is actively recruiting participants. Contact the research team at trialmanagement@prinsesmaximacentrum.nl for enrollment information.
Where is the NCT05327894 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Clayton, Australia, Adelaide, Australia, Clayton, Australia and 11 additional locations.
Who is sponsoring the NCT05327894 clinical trial?
NCT05327894 is sponsored by Princess Maxima Center for Pediatric Oncology. The principal investigator is Janine Stutterheim, Dr at Princess Maxima Center for Pediatric Oncology in The Netherlands. The trial plans to enroll 160 participants.
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