Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Last updated: March 1, 2024
Sponsor: Amgen
Overall Status: Terminated

Phase

3

Condition

Leukemia

Treatment

Standard of Care Chemotherapy

Blinatumomab

Clinical Study ID

NCT02013167
00103311
2013-000536-10
  • Ages > 18
  • All Genders

Study Summary

The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.

Eligibility Criteria

Inclusion

  • Subjects with Philadelphia negative B-precursor ALL, with any of the following:

  • refractory to primary induction therapy or refractory to salvage therapy,

  • in untreated first relapse with first remission duration <12 months

  • in untreated second or greater relapse

  • relapse at any time after allogeneic HSCT

  • Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.

  • Greater than 5% blasts in the bone marrow

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

  • Malignancy other than ALL within 5 years before blinatumomab treatment, except for adequately treated selected cancers without evidence of disease

  • Diagnosis of Burkitt's leukemia according to World Health Organization classification, or human immunodeficiency virus (HIV), Hepatitis B or C, or other clinically significant disorder

  • Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement

  • Isolated extramedullary disease

  • Current autoimmune disease or history of autoimmune disease with potential CNS involvement

  • Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment

  • Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment

  • Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)

  • Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy

  • Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.

Study Design

Total Participants: 405
Treatment Group(s): 2
Primary Treatment: Standard of Care Chemotherapy
Phase: 3
Study Start date:
January 03, 2014
Estimated Completion Date:
March 14, 2017

Study Description

Adults with relapsed/refractory B-cell precursor ALL were randomized in a 2:1 ratio to receive blinatumomab or 1 of 4 pre-specified, investigator-chosen, SOC chemotherapy regimens. Randomization was stratified by age (< 35 years vs ≥ 35 years of age), prior salvage therapy (yes vs no), and prior allogeneic HSCT (yes vs no) as assessed at the time of consent.

The study consisted of up to a 3-week screening and pre-phase period, a treatment period consisting of induction with 2 cycles of either blinatumomab or SOC chemotherapy, a consolidation phase of up to 3 additional cycles of protocol-specified therapy, and a maintenance phase for up to an additional 12 months with protocol-specified therapy. A safety follow-up visit 30 days after the last dose of protocol-specified therapy and a long-term follow-up period were included. The long-term follow-up part of the study was discontinued prematurely based on a recommendation from the data monitoring committee (DMC) that the study be stopped for benefit.

Connect with a study center

  • Research Site

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Research Site

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Research Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Research Site

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Research Site

    Prahran, Victoria 3181
    Australia

    Site Not Available

  • Research Site

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Research Site

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Research Site

    Salzburg, 5020
    Austria

    Site Not Available

  • Research Site

    Wels, 4600
    Austria

    Site Not Available

  • Research Site

    Wien, 1090
    Austria

    Site Not Available

  • Research Site

    Antwerpen, 2060
    Belgium

    Site Not Available

  • Research Site

    Brugge, 8000
    Belgium

    Site Not Available

  • Research Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Ghent, 9000
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Research Site

    Yvoir, 5530
    Belgium

    Site Not Available

  • Research Site

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Research Site

    Sofia, 1756
    Bulgaria

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Research Site

    Montréal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Research Site

    Brno, 625 00
    Czechia

    Site Not Available

  • Research Site

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Research Site

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Research Site

    Praha 2, 128 20
    Czechia

    Site Not Available

  • Research Site

    Creteil Cedex, 94010
    France

    Site Not Available

  • Research Site

    Créteil, 94010
    France

    Site Not Available

  • Research Site

    Le Chesnay, 78157
    France

    Site Not Available

  • Research Site

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Research Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Research Site

    Pessac Cedex, 33604
    France

    Site Not Available

  • Research Site

    Pierre-Benite, 69495
    France

    Site Not Available

  • Research Site

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Research Site

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Research Site

    Berlin, 12200
    Germany

    Site Not Available

  • Research Site

    Essen, 45147
    Germany

    Site Not Available

  • Research Site

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Research Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Research Site

    Hannover, 30625
    Germany

    Site Not Available

  • Research Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Research Site

    Kiel, 24116
    Germany

    Site Not Available

  • Research Site

    Köln, 50937
    Germany

    Site Not Available

  • Research Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Research Site

    München, 81377
    Germany

    Site Not Available

  • Research Site

    Münster, 48149
    Germany

    Site Not Available

  • Research Site

    Tübingen, 72076
    Germany

    Site Not Available

  • Research Site

    Ulm, 89081
    Germany

    Site Not Available

  • Research Site

    Würzburg, 97080
    Germany

    Site Not Available

  • Research Site

    Athens, 11527
    Greece

    Site Not Available

  • Research Site

    Ioannina, 45110
    Greece

    Site Not Available

  • Research Site

    Patra, 26500
    Greece

    Site Not Available

  • Research Site

    Thessaloniki, 57010
    Greece

    Site Not Available

  • Research Site

    Dublin, 8
    Ireland

    Site Not Available

  • Research Site

    Haifa, 31096
    Israel

    Site Not Available

  • Research Site

    Jerusalem, 91031
    Israel

    Site Not Available

  • Research Site

    Petah Tikva, 49100
    Israel

    Site Not Available

  • Research Site

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Research Site

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Research Site

    Bari, 70124
    Italy

    Site Not Available

  • Research Site

    Bergamo, 24127
    Italy

    Site Not Available

  • Research Site

    Bologna, 40138
    Italy

    Site Not Available

  • Research Site

    Firenze, 50134
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    Novara, 28100
    Italy

    Site Not Available

  • Research Site

    Palermo, 90146
    Italy

    Site Not Available

  • Research Site

    Roma, 00133
    Italy

    Site Not Available

  • Research Site

    Torino, 10126
    Italy

    Site Not Available

  • Research Site

    Venezia, 30174
    Italy

    Site Not Available

  • Research Site

    Verona, 37134
    Italy

    Site Not Available

  • Research Site

    Busan, 614-735
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Research Site

    Mexico, Distrito Federal 14000
    Mexico

    Site Not Available

  • Research Site

    Mexico City, Distrito Federal 07760
    Mexico

    Site Not Available

  • Research Site

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Research Site

    Lublin, 20-081
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-776
    Poland

    Site Not Available

  • Research Site

    Wroclaw, 50-367
    Poland

    Site Not Available

  • Research Site

    Moscow, 125167
    Russian Federation

    Site Not Available

  • Research Site

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Research Site

    Petrozavodsk, 185019
    Russian Federation

    Site Not Available

  • Research Site

    Saratov, 410012
    Russian Federation

    Site Not Available

  • Research Site

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Research Site

    Salamanca, Castilla León 37007
    Spain

    Site Not Available

  • Research Site

    Badalona, Cataluña 08916
    Spain

    Site Not Available

  • Research Site

    Valencia, Comunidad Valenciana 46026
    Spain

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  • Research Site

    Madrid, 28041
    Spain

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  • Research Site

    ChangHua, 50006
    Taiwan

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  • Research Site

    Taichung, 40447
    Taiwan

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  • Research Site

    Tainan, 70403
    Taiwan

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  • Research Site

    Taipei, 10002
    Taiwan

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  • Research Site

    Adana, 01330
    Turkey

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  • Research Site

    Ankara, 06100
    Turkey

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  • Research Site

    Istanbul, 34093
    Turkey

    Site Not Available

  • Research Site

    Izmir, 35340
    Turkey

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  • Research Site

    Bristol, BS2 8ED
    United Kingdom

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  • Research Site

    London, NW3 2PF
    United Kingdom

    Site Not Available

  • Research Site

    Oxford, OX3 7LJ
    United Kingdom

    Site Not Available

  • Research Site

    Sheffield, S10 2JF
    United Kingdom

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  • Research Site

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Research Site

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Research Site

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    San Francisco, California 94143
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21201
    United States

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  • Research Site

    Boston, Massachusetts 02215
    United States

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  • Research Site

    Rochester, Minnesota 55905
    United States

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  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    New York, New York 10065
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Research Site

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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