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

NCT05327894 Phase 3 RECRUITING

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.

Details

Lead sponsor	Princess Maxima Center for Pediatric Oncology
Phase	Phase 3
Status	RECRUITING
Enrolment	160
Start date	2022-12-15
Completion	2030-09

Conditions

• Acute Lymphoblastic Leukemia
• Mixed Phenotype Acute Leukemia

Interventions

• Blinatumomab
• Blinatumomab

Primary outcomes

• Event free survival (EFS). — 5 years
  The primary endpoint is EFS, defined as the time from diagnosis to resistance to induction, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.

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