A Phase 1b Open-label Study to Investigate Safety, Tolerability and Pharmacokinetics of Intravenous Blinatumomab in Japanese Adult Subjects With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)
Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)
Oda Kazunori
Amgen K.K.
Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo
+81-80-7217-8592
clinicaltrials_japan@amgen.com
Local Contact
Amgen K.K.
Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo
+81-80-7217-8592
clinicaltrials_japan@amgen.com
Not Recruiting
Jan. 08, 2025
Jan. 08, 2025
10
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
1. Japanese adult participants >= 18 years and <= 70 years at enrollment.
2. Participant should have newly diagnosed B-cell precursor (BCP) Philadelphia-negative ALL in CR/CRh after induction/consolidation therapy with any MRD (+ or -).
3. CR/CRh by the end of induction and 3 blocks of consolidation chemotherapy with ALL MRD2008/2019/2023 protocol regimen or 3 blocks of Hyper-CVAD.
4. Bone marrow function as defined below:
Absolute neutrophil count (ANC) (Neutrophils) >= 500/uL
Platelets >= 50.000/uL (transfusion permitted)
5. 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
6. Eastern Cooperative Oncology Group performance status (ECOG PS) <= 2.
Disease Related
1. 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.
Other Medical Conditions
2. 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 disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or movement disorders).
3. Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
4. Active uncontrolled infection requiring therapy.
5. History of other malignancy within the past 3 years, with the following exceptions:
Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Adequately treated breast ductal carcinoma in situ without evidence of disease.
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
Prior/Concomitant Therapy
6. Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus. In Japan, follow the JSH Guidelines for the Management of Hepatitis B Virus Infection version 4 (The Japan Society of Hepatology, 2022) for the screening of Hepatis B virus infection.
8. Radiotherapy within 4 weeks prior to study treatment.
Prior/Concurrent Clinical Study Experience
9. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). This does not apply to other investigational procedures or participation in observational research studies while participating in this study are excluded.
Other Exclusions
10. Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 48 hours after the last dose of blinatumomab.
11. Participants who are breastfeeding or who plan to breastfeed while on study through 48 hours after the last dose of blinatumomab.
12. Participants planning to become pregnant or donate eggs while on study through 48 hours after the last dose of blinatumomab.
13. Participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
14. Participant has known hypersensitivity to blinatumomab or to any component of the product formulation.
15. Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g.,Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
16. History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures, or completion.
18age old over
70age old under
Both
B-precursor Acute Lymphoblastic Leukemia
Experimental : Blinatumomab
Participants affected by B-ALL will receive blinatumomab as an intravenous (IV) infusion.
Interventions:
Drug: Blinatumomab
1. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 31 weeks]
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. A serious AE (SAE) is defined as any untoward medical occurrence that is: immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect.
2. Number of Participants Experiencing Adverse Events of Interest (EOI) [Time Frame: Up to 31 weeks]
1. Steady-state Concentration (Css) of Blinatumomab [Time Frame: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29]
2. Clearance (CL) of Blinatumomab [Time Frame: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29]
3. Number of Participants Achieving Minimal Residual Disease (MRD) After Each Cycle of Blinatumomab [Time Frame: Cycles 1-4: Day 29 (each cycle is 6 weeks)]
4. Number of Participants Achieving Hematologic Complete Remission (CR) [Time Frame: Cycles 1-4: Day 29 (each cycle is 6 weeks)]
5. Number of Participants Achieving Hematologic CR with Partial Peripheral Count Recovery (CRh) [Time Frame: Cycles 1-4: Day 29 (each cycle is 6 weeks)]
Amgen K.K.
Fukushima Medical University Hospital IRB
1 Hikarigaoka, Fukushima-shi, Fukushima
Approval
Nov. 13, 2024
Yes
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
