Dénia, Spain

Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL

Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion （DLI） treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion （DLI） treatment after relapse were enrolled. 1. Age ≤65 years old 2. Stable vital signs 3. No severe infection 4. No grade II-IV graft-versus-host disease 5. No organ failure Exclusion criteria 1. Age >65 years old 2. Unstable vital signs 3. Complicated with severe infection 4. Complicated with grade II-IV graft-versus-host disease 5. Organ failure such as heart, liver, kidney, etc. 6. Complicated with central nervous system leukemia 7. Drug allergy to the treatment regimen Treatment regimen B-ALL patients were regularly followed up after allogeneic hematopoietic stem cell transplantation. When relapse occurred, Blinatumomab was given sequentially after DLI, and the second course of treatment was conducted 1-2 months after DLI. MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）. Hematologic relapse patients were given Blinatumomab 9μg d1-4,11.66μg d5-7,28μg d8 （a total of 8 to 21 days）, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）. The duration of using Blinatumomab was determined according to the patient's tolerance, economic situation and other comprehensive factors. Main observation and statistical indicators Overall survival after relapse, disease-free survival, incidence of cytokine release syndrome （CRS）, incidence of acute/chronic graft-versus-host disease （GVHD） after treatment, incidence of infection, incidence of hematological adverse reactions, etc.Compared with patients receiving usual care.

Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab

This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.

Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

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.

Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

Nephrotic syndrome (NS) in children is characterized by excessive proteinuria, hypoalbuminemia, hyperlipidemia, and edema. Steroid-resistant nephrotic syndrome (SRNS) occurs in about 15-20% of children with NS, with a poor response to steroid therapy. SRNS can further be complicated by resistance or intolerance to calcineurin inhibitors (CNI), commonly used as first-line therapies. This study aims to explore the use of Blinatumomab, a bispecific T-cell engager targeting CD19-positive B cells, in treating children with CNI-resistant or intolerant hormone-resistant nephrotic syndrome. The study will follow a single-center, open-label design, enrolling 6 pediatric patients between the ages of 2 and 17. These patients will receive two 5-day courses of low-dose Blinatumomab administered intravenously. Outcomes will include the rate of complete or partial remission of proteinuria, safety assessments, and immune marker analysis. By targeting B cells, Blinatumomab may address the underlying immune dysfunction contributing to disease progression in these patients. The study will also evaluate the safety of short-term Blinatumomab use in this pediatric population.

Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Primary Objectives - Phase I: To determine the minimum safe and biologically effective dose of asciminib in combination with asciminib - Phase II: To evaluate the rate of NGS measurable residual disease (MRD) negativity using the clonoSEQ® assay in cohort 1 (newly diagnosed Ph-positive ALL) and the overall response (CR+CRi) rate in cohort 2 (relapsed/refractory disease). Secondary Objectives - To evaluate other clinical efficacy endpoints (complete molecular response [CMR] rate, CR rate, relapse-free survival and overall survival) - To determine the safety of the combination regimen Exploratory Objectives - To characterize the role of ABL1 kinase domain mutations on treatment failure and relapse - To assess concordance/discordance between MRD assessed by PCR for BCR::ABL1 and next-generation sequencing MRD - To determine the effect of the combination regimen on immune cell subsets

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia