Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed… (NCT06649006) | Clinical Trial Compass
CompletedPhase 1
Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)
Japan6 participantsStarted 2025-01-08
Plain-language summary
The main objective of the study is to evaluate safety and tolerability of blinatumomab in adult Japanese participants with newly diagnosed B-ALL.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Japanese adult participants ≥ 18 years and ≤ 70 years at enrollment.
* Participant should have newly diagnosed B-cell precursor (BCP)
* Philadelphia-negative ALL in CR/CRh after induction/consolidation therapy with any MRD (+ or -).
* CR/CRh as defined in Section 11.10, Appendix 10 after induction and at any time during consolidation chemotherapy with ALL MRD2008/2019/2023 protocol regimen or 3 blocks of Hyper-CVAD.
* Bone marrow function as defined below:
* Absolute neutrophil count (ANC) (Neutrophils) ≥500/μL
* Platelets ≥50.000/μL (transfusion permitted)
* Adequate renal and hepatic function:
* Total bilirubin (TBL) ≤ 2.0 x upper limit of normal (ULN) (ULN; unless Gilbert's Disease or if liver involvement with leukemia)
* Creatinine clearance ≥50 mL/min/1.73 m\^2
* Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
Exclusion Criteria:
Disease Related
* Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening CSF demonstrates leukemic blasts, participants must receive intrathecal treatment and demonstrate negative CSF before enrollment and starting blinatumomab infusion.
* Immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start of protocol-specified therapy.
Other Medical Conditions
* History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g., seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's …
What they're measuring
1
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 31 weeks
2
Number of Participants Experiencing Adverse Events of Interest (EOI)