A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL
Sponsor: Amgen
This observational or N/A phase trial investigates B Cell Precursor Acute Lymphoblastic Leukemia and is currently actively recruiting participants. Amgen leads this study, which shows 44 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Status Flow
Change History
44 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
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Apr 28, 2026 — May 4, 2026 [daily]
Recruiting
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Apr 17, 2026 — Apr 28, 2026 [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE1/PHASE2
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE1/PHASE2
▶ Show 39 earlier versions
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE1/PHASE2
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE1/PHASE2
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Sep 2025 — Dec 2025 [monthly]
Recruiting PHASE1/PHASE2
Status: Active Not Recruiting → Recruiting
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Feb 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE1/PHASE2
Status: Recruiting → Active Not Recruiting
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Nov 2024 — Feb 2025 [monthly]
Recruiting PHASE1/PHASE2
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Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE1/PHASE2
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Sep 2024 — Oct 2024 [monthly]
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE1/PHASE2
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE1_PHASE2
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Apr 2024 — Jun 2024 [monthly]
Recruiting PHASE1_PHASE2
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Mar 2024 — Apr 2024 [monthly]
Recruiting PHASE1_PHASE2
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Feb 2024 — Mar 2024 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2024 — Feb 2024 [monthly]
Recruiting PHASE1_PHASE2
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Dec 2023 — Jan 2024 [monthly]
Recruiting PHASE1_PHASE2
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Nov 2023 — Dec 2023 [monthly]
Recruiting PHASE1_PHASE2
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Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE1_PHASE2
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Sep 2023 — Oct 2023 [monthly]
Recruiting PHASE1_PHASE2
Phase: PHASE1 → PHASE1_PHASE2
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Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE1
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Jul 2023 — Aug 2023 [monthly]
Recruiting PHASE1
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Jun 2023 — Jul 2023 [monthly]
Recruiting PHASE1
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May 2023 — Jun 2023 [monthly]
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Apr 2023 — May 2023 [monthly]
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Feb 2023 — Apr 2023 [monthly]
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Jan 2023 — Feb 2023 [monthly]
Recruiting PHASE1
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Oct 2022 — Jan 2023 [monthly]
Recruiting PHASE1
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Jul 2022 — Oct 2022 [monthly]
Recruiting PHASE1
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Jun 2022 — Jul 2022 [monthly]
Recruiting PHASE1
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May 2022 — Jun 2022 [monthly]
Recruiting PHASE1
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Apr 2022 — May 2022 [monthly]
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Feb 2022 — Apr 2022 [monthly]
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Jan 2022 — Feb 2022 [monthly]
Recruiting PHASE1
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Oct 2021 — Jan 2022 [monthly]
Recruiting PHASE1
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Sep 2021 — Oct 2021 [monthly]
Recruiting PHASE1
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May 2021 — Sep 2021 [monthly]
Recruiting PHASE1
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Feb 2021 — May 2021 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
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Jan 2021 — Feb 2021 [monthly]
Not Yet Recruiting PHASE1
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Dec 2020 — Jan 2021 [monthly]
Not Yet Recruiting PHASE1
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Sep 2020 — Dec 2020 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility 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.
Contact Information
- Amgen
- BeOne Medicines
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Adelaide, Australia , Akita, Japan , Ankara, Turkey (Türkiye) , Ankara, Turkey (Türkiye) , Ann Arbor, United States , Augsburg, Germany , Badalona, Spain , Baltimore, United States , Barcelona, Spain , Beijing, China and 99 more locations