Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

Completed · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia

In brief

The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

Key facts

Study ID

NCT04524455

Run by

Amgen

People needed

17

Starts

2020-10-02

Expected to finish

2023-01-24

Last updated by the study team

2024-04-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years at enrollment.
• Greater than or equal to 5% blasts in the bone marrow.
• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
• Negative pregnancy test in women of childbearing potential.

You may not qualify if…

• Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
• Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of Chicago — Chicago, Illinois, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Ordensklinikum Linz Elisabethinen — Linz, Austria
• Hôpital Saint Louis — Paris, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France
• Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main — Frankfurt am Main, Germany
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany
• Universitaetsklinikum Regensburg — Regensburg, Germany
• Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi — Bologna, Italy
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia, Italy
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• Hospital Universitari Germans Trias i Pujol — Badalona, Catalonia, Spain
• Hospital Clinic i Provincial de Barcelona — Barcelona, Catalonia, Spain
• University College London — London, United Kingdom

Full record on ClinicalTrials.gov

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