search
Back to results

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

Primary Purpose

Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Blinatumomab
Extension of LTFU as per ProtocolAmendment7 7Jun18
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

Eligibility Criteria

0 Years - 17 Years (Child)All Sexes

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 9, 2014
Last Updated
November 10, 2022
Sponsor
Amgen
search

1. Study Identification

Unique Protocol Identification Number
NCT02187354
Brief Title
Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL
Acronym
RIALTO
Official Title
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)
Study Type
Expanded Access

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
AMG103, Blincyto
Intervention Description
A single cycle of blinatumomab (CIVI) treatment is 6wks, 4wks of treatment followed by a 2wk treatment-free interval. Up to 5 cycles will be administered per subject. In the first cycle, for patients with an M3 bone marrow, the initial dose will be 5μg/m2/day for the first 7days, escalated to 15μg/m2/day on D8-D29. For all subsequent cycles 15μg/m2/day will be the dose for all 4wks of continuous treatment. In case of M2 bone marrow or M1 bone marrow with an MRD relapse at screening, the initial dose will start at 15μg/m2/day for the first 7days of treatment & no dose step at D8. For all subsequent cycles the dose will remain 15μg/m2/day. A dose of 9μg/day for the initial dose (if applicable) & 28μg/day for the escalated dose after dose step should not be exceeded.
Intervention Type
Other
Intervention Name(s)
Extension of LTFU as per ProtocolAmendment7 7Jun18
Intervention Description
LTFU (Long Term Follow-Up) will extend past 18 months for patients already ended the study/still on study or to be enrolled at European sites if they did not receive a transplantation after blinatumomab treatment. For subjects to be included in the additional LTFU, data will be captured until subjects are 18yrs old (every 6 months by phone contact). The following will be captured: relapse (medullary or extra-medullary relapse and its specific location), second tumor (which type), alive/died and cause of death, hospitalization and reason for hospitalization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
17 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Research Site
City
Monza (MB)
ZIP/Postal Code
20900
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Research Site
City
Zuerich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34979020
Citation
Locatelli F, Zugmaier G, Mergen N, Bader P, Jeha S, Schlegel PG, Bourquin JP, Handgretinger R, Brethon B, Rossig C, Kormany WN, Viswagnachar P, Chen-Santel C. Blinatumomab in pediatric relapsed/refractory B-cell acute lymphoblastic leukemia: RIALTO expanded access study final analysis. Blood Adv. 2022 Feb 8;6(3):1004-1014. doi: 10.1182/bloodadvances.2021005579.
Results Reference
background
PubMed Identifier
32709851
Citation
Locatelli F, Zugmaier G, Mergen N, Bader P, Jeha S, Schlegel PG, Bourquin JP, Handgretinger R, Brethon B, Rossig C, Chen-Santel C. Blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia: results of the RIALTO trial, an expanded access study. Blood Cancer J. 2020 Jul 24;10(7):77. doi: 10.1038/s41408-020-00342-x. No abstract available. Erratum In: Blood Cancer J. 2021 Feb 1;11(2):28. Blood Cancer J. 2021 Oct 27;11(10):173.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs