A Phase 3 interventional study of Blinatumomab and Blinatumomab in Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, sponsored by Princess Maxima Center for Pediatric Oncology. Recruiting at 124 sites in 24 countries. Open to participants aged 1 Day to 1 Year. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Princess Maxima Center for Pediatric Oncology · Phase 3, Interventional, and Treatment
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.
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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 491 are open to participants now.
This study's planned enrollment of 160 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Princess Maxima Center for Pediatric Oncology is the lead sponsor of 15 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria for blinatumomab:
If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
Subject is defined as MR if \> 6months of age at diagnosis, OR \< 6 months of age with White Blood cell Count (WBC) \< 300 at diagnosis and good prednisone response. Subject gets 1st cycle of blinatumomab. If MRD is \>0.01%, after 1st cycle of blinatumomab, subject will be allocated to HR treatment from that phase, and will be eligible for HSCT. If MRD is undetectable or \< 0.01% after the 1st cycle of blinatumomab (TP2) patient will be eligible for replacement of MARMA by 2nd cycle of blinatumomab after receipt of lymphoid style consolidation (Protocol IB) or of myeloid style consolidation (ADE/MAE).
Drug: Blinatumomab
Subject is defined as HR if \< 6 months of age with WBC \> 300 at diagnosis OR poor prednisone response. Also MR patients with end of induction MRD ≥ 1%, or MRD \> 0.01% after the 1st cycle of blinatumomab, will be allocated to HR treatment. Subject gets 1 cycle of blinatumomab. Thereafter patient is eligible for hematopoietic stem cell transplantation (HSCT) with or without experimental therapy in an investigational window.
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.
Also known as: Cycle 1
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Also known as: Cycle 2
Event free survival (EFS).
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.
Time frame: 5 years
Overall survival
The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
Time frame: 8 years
Endpoints by risk group
The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
Time frame: 8 years
Outcome for the entire study cohort and according to risk group
Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated.
Time frame: 8 years
Minimal Residual Disease
MRD response as defined in the protocol and frequencies of MRD levels
Time frame: 8 years
CD19 (cluster of differentiation antigen 19) negative relapse
Proportion of CD19 negative relapses in the entire study cohort and according to risk group
Time frame: 8 years
Myeloid lineage switches
Proportion of myeloid lineage switches in the entire study cohort and according to risk group
Time frame: 8 years
Grade ≥3 adverse event
Proportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases.
Time frame: 8 years
Grade ≥2 cardiac disorders
Proportion of grade ≥2 cardiac disorders at 2 and 5 years after diagnosis
Time frame: 5 years
Overall survival after 1st relapse
Overall survival (OS) after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group
Time frame: 8 years
Showing the first 100 of 124 sites across 24 countries.
Plan to share: Yes — all individual participant data that underlie results in a publication
Supporting information: Csr
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Princess Maxima Center for Pediatric Oncology