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Clinical Trials in Israel / NCT04521231
Active, not recruiting Phase 1/2

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

NCT04521231 · tracked via the Priya Life Science Israel tracker
Sponsor
Phase
Phase 1/2
Started
2021-01-04
Last updated
2026-05-28

Condition(s) studied

B Cell Precursor Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Blinatumomab →

Blinatumomab: Blinatumomab will be administered as a subcutaneous (SC) injection.

Study summary

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab.

The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years). * Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of informed consent. * Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of informed consent. * Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL. * Relapsed or Refractory B-precursor ALL at any time after first salvage therapy. * Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT). * Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment. * Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment. * Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample. * Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. * Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%. * Participants aged \< 16 years old: Lansky Performance Score ≥ 50%. * Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible. * Ph-IIM: BM function as follows: * Absolute Neutrophil Count (ANC) ≥ 500/μL * Platelet count ≥ 50 000/μL (transfusion permitted) * Hemoglobin level ≥ 9 g/dL (transfusion permitted) The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia. If CSF leukemia is present subjects will have to receive intrathecal therapy and have documented negative CSF prior to enrolling. * History or presence of clinically relevant CNS pathology (excluding headache) such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including immune effector cell-associated neurotoxicity syndrome (ICANS) from prior chimeric antigen receptor T-cell (CAR T) or other T cell engager therapies. * Isolated Extramedullary (EM) Disease. * For Ph-IIM only: Current EM disease or presence of circulating leukemia blasts. * Current autoimmune disease or history of autoimmune disease with potential CNS involvement. * Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication. * Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance. * Testicular leukemia. * History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy. * Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy. * Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions). * Immunotherapy within 4 weeks before start of protocol-specified therapy. * Prior failed cluster of differentiation (CD19) directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed (with demonstrated continued CD19+ expression), if treatment ended more than 4 weeks prior to start of protocol therapy and no prior CNS complications. * Currently receiving treatment in or less than 30 days or 5 half-lives since ending treatment on another investigational study(ies). * Abnormal screening laboratory parameters. * Female participant: Pregnant or breastfeeding or planning to become pregnant or donate eggs, or expected to breastfeed during treatment and for 96 hours after the last dose of investigational product (SC blinatumomab). The above is a summary, other exclusion criteria details may apply.

Primary outcome measure(s)

Trial sites (109)

FacilityCityRegionStatus
University of California San Francisco Fresno at Community Cancer Institute Clovis California
City of Hope National Medical Center Duarte California
University of Illinois Chicago Chicago Illinois
Johns Hopkins University Baltimore Maryland
C.S. Mott Children's Hospital - University of Michigan Ann Arbor Michigan
Roswell Park Comprehensive Cancer Center Buffalo New York
New York University Grossman School of Medicine and New York University Langone Hospitals New York New York
Albert Einstein College of Medicine - Montefiore Medical Center The Bronx New York
Childrens Hospital of Philadelphia Philadelphia Pennsylvania
St Jude Childrens Research Hospital Memphis Tennessee
University of Texas MD Anderson Cancer Center Houston Texas
Fred Hutchinson Cancer Center Seattle Washington
The Medical College of Wisconsin Milwaukee Wisconsin
Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos Aires Buenos Aires
Sanatorio Allende Córdoba Córdoba Province
Instituto Alexander Fleming Buenos Aires Argentina
Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno Ciudad Autonoma Buenos Aires Argentina
Sydney Childrens Hospital Randwick New South Wales
Westmead Hospital Westmead New South Wales
Queensland Childrens Hospital South Brisbane Queensland
Royal Adelaide Hospital Adelaide South Australia
Monash Medical Centre Clayton Victoria
Austin Health, Austin Hospital Heidelberg Victoria
The Alfred Hospital Melbourne Victoria
Perth Childrens Hospital Nedlands Western Australia
Universitaetsklinikum Allgemeines Krankenhaus Wien Vienna Austria
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne Yvoir Belgium
Hospital Sirio Libanes Brasilia Brasília Federal District
Instituto Medicina Integral Imip Recife Pernambuco
Hosp de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
Fundacao Amaral Carvalho Jaú São Paulo
Hosp Clin Fac Med Ribeirao Preto Usp Ribeirão Preto São Paulo
Instituto Onco Ped Graac Unifesp São Paulo São Paulo
Arthur J E Child Comprehensive Cancer Centre Calgary Alberta
University of Alberta Edmonton Alberta
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia
The Hospital for Sick Children Toronto Ontario
Princess Margaret Cancer Centre Toronto Ontario
Beijing Childrens Hospital, Capital Medical University Beijing Beijing Municipality
Fujian Medical University Union Hospital Fuzhou Fujian

+ 69 more sites — see the full list on the official registry below.

More Amgen trials in Israel

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04521231 on ClinicalTrials.gov ↗ ← All trials in Israel