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Efficacy and Toxicity of Blinatumomab in the French ATU for Adult BCP-ALL R/R, or With MRD+ (FRENCH-CYTO)

NCT03751072 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2026-02-27

No results posted yet for this study

Summary

The outcome of young adults (18-60 years) with ALL has been dramatically improved by the use of pediatric-inspired trials. About 60% of these young adult patients will be cured at 5 years. In this context, early evaluation of minimal residual disease (MRD) at complete remission has been shown to be one of the most powerful prognostic factor, but also predictive of the benefit of allogeneic stem cell transplantation (ASCT). Despite this global improvement, about 30% of patients experience a relapse and will be exposed to be refractory to salvage therapy or to early disease escape. In adult ALL, the most important prognostic factors at relapse are : the time from first CR to relapse, the achievement of a second complete remission (CR), and the feasibility of ASCT.

Blinatumomab is a bispecific T-cell engager that recruits T-cell on CD19 positive blast cells and induces anti-leukemic cytotoxicity. In a phase 3 trial in relapse/refractory Philadelphia-negative (Ph-) ALL, 43% of patients achieved a CR or CR with partial hematological recovery (CRh), with the majority of responses occurring within the first cycle. In patients with positive MRD (MRD+) BCP-ALL, blinatumomab resulted in complete MRD response in 78% of patients after one cycle.

Between 2012 and 2016, blinatumomab was available in France for R/R and MRD+ ALL adult patients through the French Compassionate Use Program. About 92 adult ALL were treated at different stages of the disease in 27 centers.

Conditions

  • Acute Lymphoblastic Leukemia, in Relapse
  • Acute Lymphoblastic Leukemia With Failed Remission

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Group for Research in Adult Acute Lymphoblastic Leukemia

    lead OTHER

Principal Investigators

  • Nicolas BOISSEL, MD · 142499643

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2018-11-30
Completion
2019-01-30

Countries

  • France

Study Locations

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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 NCT03751072 on ClinicalTrials.gov