blinatumomab
blinatumomab: sourced relationships with 1 company · 41 clinical trials tracked · 1 FDA decision.
blinatumomab evidence translation
What we can confirm
1 FDA record · 41 tracked trials
What it means
What to watch
Prepared research question
How could blinatumomab → AMGN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| AMGEN INC (AMGN) Reported 2014-12-03 · Current development: unknownSource Leukemia, Acute Lymphoblastic; Systemic Lupus Erythematosus;… | Phase 3 |
Clinical Trial Registry Records (41)showing 10 most recent
A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia
Primary endpoint: Overall Survival (OS)
Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)
Primary endpoint: safety and adverse events
A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
Primary endpoint: Safety and adverse events (AEs).
A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)
Primary endpoint: Dose limiting toxicities (Safety run-in: Cohort A)
Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia
Primary endpoint: Safety and adverse events (AEs)
A Phase 1/2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia
Primary endpoint: Phase I: Maximum Tolerated Dose/MTD
Open-label, Phase I/II Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL
Primary endpoint: Part 1 Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) occurring during cycle 1 (debulking induction)
Immune-targeted Combination With Acute Lymphoblastic Leukemia-like Chemotherapy for Adult of Acute Leukemia of Ambiguous Lineage: A Prospective, Single-arm, Multicenter Clinical Study
Primary endpoint: overall survival (OS)
An Open-Label, Single-Arm, Phase II Exploratory Study of ABL and JAK Kinase Inhibitors With Chemotherapy and Venetoclax in Adult Patients With Ph-like ALL
Primary endpoint: Rate of flow cytometry-minimal residual disease (flow-MRD) negative complete remission at 3 months after treatment initiation
A Phase 1/1b Study Evaluating Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) and Venetoclax in Combination With Blinatumomab in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Primary endpoint: Incidence of adverse events (AEs) (Phase I)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with blinatumomab?
blinatumomab has dated SEC/FDA relationship records for AMGEN INC.
How many clinical trials involve blinatumomab?
BioSniper tracks 41 clinical trials involving blinatumomab.
What is blinatumomab's latest FDA decision?
The most recent tracked FDA decision for blinatumomab is Approval for 1 INDICATIONS AND USAGE BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with: CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. ( 1.1 ) Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). ( 1.2 ) CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. ( 1.3 ) 1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adult and pediatric patients one month and older. 1.2 Relapsed or Refractory B-cell Precursor ALL BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older. 1.3 B-cell Precursor ALL in the Consolidation Phase BLINCYTO is indicated for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older., dated December 3, 2014.