A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

Phase 2Active Not RecruitingNCT07134088

Amgen104 enrolled

Overview

The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia

Interventions

BlinatumomabDRUG

Blinatumomab will be administered as a SC injection for up to 5 cycles (each cycle will be 35 days).

Eligibility

Sex: ALLMin age: 28 DaysMax age: 4383 Days

Medical Language ↔ Plain English

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.

Locations (5)

Lucile Packard Childrens Hospital Stanford

Palo Alto, California, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St Jude Childrens Research Hospital

Memphis, Tennessee, United States

Seattle Childrens Hospital

Seattle, Washington, United States

Outcomes

Primary Outcomes

Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)

Time frame: Up to 29 days

Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to approximately 7 months

Phase 1b: Number of Participants who Experienced Serious TEAEs

Time frame: Up to 2 years and 7 months

Phase 1b: Number of Participants who Experienced Treatment-related TEAEs

Time frame: Up to approximately 7 months

Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)

Time frame: 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

Time frame: Up to 70 days

Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles

MRD negative response = MRD level \< 10\^-4 (0.01%).

Time frame: Up to 70 days

Secondary Outcomes

Phase 1b: Number of Participants who had CR/CRh Within the First 2 Cycles

Time frame: Up to 70 days

Phase 1b: Number of Participants who had CR Within the First 2 Cycles

Time frame: Up to 70 days

Phase 1b: Number of Participants who had CR/CRh/Complete Remission with Incomplete Hematological Recovery (CRi) or Blast Free Hypoplastic or Aplastic Bone Marrow (BM) Within the First 2 Cycles

Data from ClinicalTrials.gov

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