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

November 20, 2018 updated by: Group for Research in Adult Acute Lymphoblastic Leukemia

Efficacy and Toxicity of Blinatumomab in the French Compassionate Use Program (ATU) for Adult Patients With B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Refractory, in Relapse, or With Positive Minimal Residual Disease.

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in term of overall survival in both R/R (first cohort) and MRD positive (second cohort) patients.

To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in term of CR/CRH in R/R patients, To evaluate the efficacy in term of molecular response in both R/R and MRD+ cohorts, To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in both Ph+/Ph- ALL patients To evaluate the feasibility and the safety of blinatumomab administration in a multi-center setting.To evaluate the feasibility of allogeneic stem cell transplant after blinatumomab administration in both populations.

Study Type

Observational

Enrollment (Anticipated)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • CABANNES-HAMY Aurélie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aurélie CABANNES-HAMY
        • Principal Investigator:
          • Nicolas Boissel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients aged 18y+ with R/R or MRD+ BCP-ALL treated in the French GRAALL Network

Description

Inclusion Criteria:

Patient with Philadelphia-negative or positive (Ph+) ALL in relapse, refractory to salvage therapy, or with MRD positive ALL that received blinatumomab in the French ATU program.,

  • Patient treated in the GRAALL network,
  • Patient who does'nt object to participate in the study

Exclusion Criteria :

- none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Relapse/Refractory
MRD positive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival in R/R and MRD+ cohorts
Time Frame: 6 months
Months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rates
Time Frame: 6 months
Percent
6 months
Adverse events
Time Frame: 6 months
Percent
6 months
Disease free survival
Time Frame: 6 months
Months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Group for Research in Adult Acute Lymphoblastic Leukemia

Collaborators

Amgen

Investigators

  • Principal Investigator: Nicolas BOISSEL, MD, 142499643

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 16, 2018

Primary Completion (ANTICIPATED)

November 30, 2018

Study Completion (ANTICIPATED)

January 30, 2019

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (ACTUAL)

November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRENCH-CYTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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