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

NCT07134088 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-05-15

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

Blinatumomab

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

Sponsors & Collaborators

  • BeOne Medicines

    collaborator INDUSTRY

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
28 Days
Max Age
4383 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2028-12-05
Completion
2030-06-18
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134088 on ClinicalTrials.gov