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Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

NCT02393859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2024-05-29

Study results available
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Summary

B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.

Conditions

  • Leukemia, Acute Lymphoblastic

Interventions

DRUG

Blinatumomab

15 μg/m\^2/day as a continuous intravenous infusion (CIVI) for 4 weeks

DRUG

Dexamethasone

10 mg/m\^2/day intravenous (IV) on Days 1-6

DRUG

Vincrisitne

1.5 mg/m\^2/day IV on Days 1 and 6

DRUG

Daunorubicin

30 mg/m\^2 IV over 24 hours on Day 5

DRUG

Methotrexate

1 g/m\^2 IV over 36 hours on Day 1

DRUG

Ifosfamide

800 mg/m\^2 IV for 1 hour on Days 2-4

DRUG

PEG-asparaginase

1000 U/m\^2 IV for 2 hours or intramuscularly (IM) on Day 6

DRUG

Erwinia-asparaginase

In case of allergic reaction to PEG-asparaginase, participants could change to erwinia-asparaginase, 20,000 units/m2 every 48 hours for a total of 6 doses

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-10
Primary Completion
2019-07-17
Completion
2022-11-21

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

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 NCT02393859 on ClinicalTrials.gov