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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187354
Expanded Access Status : No longer available
First Posted : July 11, 2014
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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


Condition or disease Intervention/treatment
Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Drug: Blinatumomab Other: Extension of LTFU as per ProtocolAmendment7 7Jun18

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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)



Intervention Details:
  • Drug: Blinatumomab
    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.
    Other Name: AMG103, Blincyto
  • Other: Extension of LTFU as per ProtocolAmendment7 7Jun18
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187354


Locations
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United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45229
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38105
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84113
Austria
Research Site
Wien, Austria, 1090
France
Research Site
Marseille cedex 5, France, 13385
Research Site
Paris, France, 75019
Germany
Research Site
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
Italy
Research Site
Monza (MB), Italy, 20900
Research Site
Padova, Italy, 35128
Research Site
Roma, Italy, 00165
Switzerland
Research Site
Zuerich, Switzerland, 8032
United Kingdom
Research Site
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02187354    
Other Study ID Numbers: 20130320
2014-001700-21 ( EudraCT Number )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blinatumomab
Antineoplastic Agents