A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
NCT ID: NCT04521231
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
281 participants
INTERVENTIONAL
2021-01-04
2029-05-25
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)
Cohorts of at least 3 adult participants with R/R B-ALL will be treated with escalating doses of blinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.
Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Dose Expansion Phase: Blinatumomab SC1
Up to 4 cohorts of adult participants with R/R B-ALL will be enrolled at different dose levels to support identification of the RP2D. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.
Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations
1 cohort of adult participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the preliminary RP2D determined from the dose expansion phase, in participants with R/R B-ALL.
Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Ph-IIR: Efficacy of SC Blinatumomab in Participants with R/R B-ALL
The efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with R/R B-ALL.
Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Ph-IIM: Efficacy of SC Blinatumomab in Participants with MRD+ B-ALL
The efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with MRD+ B-ALL.
Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Interventions
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Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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).
12 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Hopital Saint Antoine
Paris, , France
City of Hope National Medical Center
Duarte, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, , Austria
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, , France
Centre Hospitalier Universitaire de Nice - Hopital l Archet
Nice, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Universitaetsklinikum Augsburg
Augsburg, , Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, , Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, , Italy
Akita University Hospital
Akita, Akita, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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Jabbour E, Zugmaier G, Agrawal V, Martinez-Sanchez P, Rifon Roca JJ, Cassaday RD, Boll B, Rijneveld A, Abdul-Hay M, Huguet F, Cluzeau T, Diaz MT, Vucinic V, Gonzalez-Campos J, Rambaldi A, Schwartz S, Berthon C, Hernandez-Rivas JM, Gordon PR, Bruggemann M, Hamidi A, Chen Y, Wong HL, Panwar B, Katlinskaya Y, Markovic A, Kantarjian H. Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia. Am J Hematol. 2024 Apr;99(4):586-595. doi: 10.1002/ajh.27227. Epub 2024 Feb 5.
Jabbour E, Lussana F, Martinez-Sanchez P, Torrent A, Rifon JJ, Agrawal V, Tormo M, Cassaday RD, Cluzeau T, Huguet F, Papayannidis C, Hernandez-Rivas JM, Rijneveld A, Fleming S, Vucinic V, Boll B, Ikezoe T, Abdul-Hay M, Savoie ML, Schuh AC, Berthon C, Schwartz S, Chiaretti S, Yuda J, Miyazaki T, Gonzalez-Campos J, Chen Y, Wong H, Choudhry J, Zugmaier G, Guest E, Gordon P, Kantarjian H. Subcutaneous blinatumomab in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: post-hoc safety and activity analysis from a multicentre, single-arm, phase 1/2 trial. Lancet Haematol. 2025 Jul;12(7):e529-e541. doi: 10.1016/S2352-3026(25)00144-9. Epub 2025 Jun 15.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-506136-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20180257
Identifier Type: -
Identifier Source: org_study_id