OncoMatch/Clinical Trials/NCT05327894
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Is NCT05327894 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Blinatumomab and Blinatumomab for acute lymphoblastic leukemia.
Treatment: Blinatumomab · Blinatumomab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Excluded: KMT2A (MLL) wild-type
Demographics
Prior therapy
Cannot have received: systemic corticosteroids (prednisone)
Exception: corticosteroids by aerosol
Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
Cannot have received: chemotherapeutic agent
any chemotherapeutic agent in the 4-week interval prior to diagnosis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05327894 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Are patients with KMT2A alterations eligible?
No. KMT2A wild-type is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 1 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify