Last updated 5 months ago
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
160 patients around the world
Available in Argentina
All infants that are eligible for this study and for whom the parents/legal
representatives give informed consent will be enrolled in this study. All patients will
receive one cycle of blinatumomab on top of the standard treatment backbone after
induction therapy. Medium risk patients, that respond well to the 1st cycle will be
treated with a 2nd cycle of blinatumomab replacing one chemo course after consolidation
therapy. If they do not respond well enough they will be treated according to the current
treatment standard. Minimal residual disease will be used to determine the response to
blinatumomab. High risk patients will be eligible for allogeneic stem cell
transplantation after the first blinatumomab cycle if they are Minimal Residual Disease
(MRD) negative (defined as < 0.01%). Also medium risk patients with insufficient MRD
response after induction or after the 1st cycle of blinatumomab will be allocated to high
risk treatment and will be eligible for allogeneic stem cell transplantation.
Princess Maxima Center for Pediatric Oncology
1Research sites
160Patients around the world
This study is for people with
Leukemia
Acute lymphoblastic leukemia
Requirements for the patient
To 365 Days
All Gender
Medical requirements
- Patients with newly diagnosed B- precursor acute lymphoblastic leukemia (ALL) or B-cell mixed phenotype acute leukemia (MPAL) according to the World Health Organization (WHO) classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement).≤365 days of age at time of diagnosis of ALL.Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
- KMT2A-germline patients.T-ALL.Age > 365 days at the time of diagnosis.Relapsed ALL.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.Additional exclusion criteria for blinatumomab:CD19 negative B-precursor ALL at diagnosis.CNS involvement (CNS2/CNS3 status) at the EOI. Patients with CNS disease at the time of diagnosis are eligible if CNS1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of induction).Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to B-cell recovery after the last dose of blinatumomab.
Sites
Hospital de Pediatría Dr. Juan P. Garrahan
Recruiting
StudyInterfant-21
SponsorPrincess Maxima Center for Pediatric Oncology
Conditions
Acute lymphoblastic leukemia
Requirements
To 365 DaysAll Gender
Unique study IDclinicaltrials.gov
NCT05327894
