Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL (RIALTO)

May 10, 2024 updated by: Amgen

An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Primary Objective:

To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments

Secondary Objective(s):

To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT.

Hypotheses:

A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated.

Study Endpoints:

  • Incidence of treatment-emergent and treatment-related adverse events
  • Incidence of CR within 2 cycles of blinatumomab
  • MRD remission within 2 cycles of blinatumomab
  • RFS
  • OS
  • Incidence of alloHSCT
  • 100-day mortality after alloHSCT

Study Design:

Multi-center, open-label, single-arm expanded access protocol

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

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

  • Austria
      • Wien, Austria, 1090
        • Research Site
  • France
      • Marseille cedex 5, France, 13385
        • Research Site
      • Paris, France, 75019
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Frankfurt am Main, Germany, 60590
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • München, Germany, 80337
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Italy
      • Monza (MB), Italy, 20900
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Roma, Italy, 00165
        • Research Site
  • Switzerland
      • Zuerich, Switzerland, 8032
        • Research Site
  • United Kingdom
      • Sheffield, United Kingdom, S10 2TH
        • Research Site
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Research Site

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

1 second to 17 years (Child)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria 101 Immunophenotypic evidence of CD19 positive B-precursor ALL (pro B-, pre B-, common ALL) 102 Age > 28 days and < 18 years at the time of informed consent/assent 103 Morphological or molecular evidence of relapsed/refractory disease, defined as one of the following:

  • Second or later bone marrow relapse (defined as M3 marrow or M2 marrow or M1 marrow but with MRD level ≥ 10E-3), or
  • Any marrow relapse after alloHSCT (defined as M3 marrow or M2 marrow or M1 marrow but with and MRD level ≥ 10E-3), or

  • Refractory to other treatments:

    • For patients in first relapse: failure to achieve a CR following a full standard reinduction chemotherapy regimen
    • For patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
  • Subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab (Note: This does not include patients who have already received blinatumomab treatment on this study, but refers only to patients outside of the 20130320 study)

Other Inclusion Criteria may apply

Exclusion Criteria 201 Any active acute Graft-versus-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment 202 Immunosuppresive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids) 203 Active (overt) ALL in the CNS (confirmed by cerebrospinal fluid [CSF] analysis) or in testes

Other Exclusion Criteria may apply

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?

Collaborators and Investigators

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

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

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

Helpful Links

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 Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimated)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130320
  • 2014-001700-21 (EudraCT Number)

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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