Clinical Trials in Japan / NCT07134088
Active, not recruiting
Phase 1/2
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
NCT07134088 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic LeukemiaMinimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
Investigational drug(s) / intervention(s)
Blinatumomab: Blinatumomab will be administered as a SC injection for up to 5 cycles (each cycle will be 35 days).
Study summary
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
Eligibility
Inclusion Criteria:
* Age ≥28 days to \<12 years at the time of informed consent/assent.
* Lansky Performance Status (LPS) of ≥ 50%.
* For Phase 1b and Phase 2 cohort in participants with R/R B-ALL:
* Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic hematopoietic stem cell transplant (HSCT).
* Greater than or equal to 5% blasts in the bone marrow (BM) is considered as relapse in the BM.
* For Phase 2 cohort in participants with MRD+ B-ALL:
* Participants with MRD+ B-ALL must have between ≥ 0.1% and \< 5% blasts in the BM.
* Prior CD19-directed therapy will be allowed (with demonstrated continued CD19+ expression) if treatment ended \>4 weeks prior to start of protocol therapy and no prior central nervous system (CNS) complications.
* Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
Exclusion Criteria:
* Active ALL in the CNS.
* History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or severe (≥ grade 3) CNS events including immune effector cell-associated neurologic syndrome (ICANS) from prior CAR-T or other T-cell engager therapies.
* Isolated EM disease.
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
* Patients with Down Syndrome are not eligible for this study.
* Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
* Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
* Presence of an acute or uncontrolled chronic infection, or any other concurrent disease or medical condition that could be worsened by the treatment or interfere with the participant's ability to comply with the study protocol.
* Allogeneic HSCT within 12 weeks before the start of blinatumomab.
Primary outcome measure(s)
- Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs) — Up to 29 days
- Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs) — Up to approximately 7 months
- Phase 1b: Number of Participants who Experienced Serious TEAEs — Up to 2 years and 7 months
- Phase 1b: Number of Participants who Experienced Treatment-related TEAEs — Up to approximately 7 months
- Phase 1b: Number of Participants who Experienced AEs of Interest (EOI) — Up to approximately 7 months
- Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 Cycles — Up to 70 days
- Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles — Up to 70 days
MRD negative response = MRD level \< 10\^-4 (0.01%).
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Lucile Packard Childrens Hospital Stanford | Palo Alto | California | |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| St Jude Childrens Research Hospital | Memphis | Tennessee | |
| Seattle Childrens Hospital | Seattle | Washington | |
| Kanagawa Childrens Medical Center | Yokohami-shi | Kanagawa |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07134088 on ClinicalTrials.gov ↗ ← All trials in Japan