Phase
Condition
Leukemia
Treatment
Standard of Care Chemotherapy
Blinatumomab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Research Site
St Leonards, New South Wales 2065
AustraliaSite Not Available
Research Site
Herston, Queensland 4029
AustraliaSite Not Available
Research Site
Adelaide, South Australia 5000
AustraliaSite Not Available
Research Site
Parkville, Victoria 3050
AustraliaSite Not Available
Research Site
Prahran, Victoria 3181
AustraliaSite Not Available
Research Site
Murdoch, Western Australia 6150
AustraliaSite Not Available
Research Site
Perth, Western Australia 6000
AustraliaSite Not Available
Research Site
Salzburg, 5020
AustriaSite Not Available
Research Site
Wels, 4600
AustriaSite Not Available
Research Site
Wien, 1090
AustriaSite Not Available
Research Site
Antwerpen, 2060
BelgiumSite Not Available
Research Site
Brugge, 8000
BelgiumSite Not Available
Research Site
Bruxelles, 1200
BelgiumSite Not Available
Research Site
Gent, 9000
BelgiumSite Not Available
Research Site
Ghent, 9000
BelgiumSite Not Available
Research Site
Leuven, 3000
BelgiumSite Not Available
Research Site
Yvoir, 5530
BelgiumSite Not Available
Research Site
Plovdiv, 4000
BulgariaSite Not Available
Research Site
Sofia, 1756
BulgariaSite Not Available
Research Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Research Site
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Research Site
Montréal, Quebec H1T 2M4
CanadaSite Not Available
Research Site
Brno, 625 00
CzechiaSite Not Available
Research Site
Hradec Kralove, 500 05
CzechiaSite Not Available
Research Site
Praha 10, 100 34
CzechiaSite Not Available
Research Site
Praha 2, 128 20
CzechiaSite Not Available
Research Site
Creteil Cedex, 94010
FranceSite Not Available
Research Site
Créteil, 94010
FranceSite Not Available
Research Site
Le Chesnay, 78157
FranceSite Not Available
Research Site
Nantes Cedex 1, 44093
FranceSite Not Available
Research Site
Paris Cedex 10, 75475
FranceSite Not Available
Research Site
Pessac Cedex, 33604
FranceSite Not Available
Research Site
Pierre-Benite, 69495
FranceSite Not Available
Research Site
Pierre-Bénite, 69495
FranceSite Not Available
Research Site
Toulouse cedex 9, 31059
FranceSite Not Available
Research Site
Berlin, 12200
GermanySite Not Available
Research Site
Essen, 45147
GermanySite Not Available
Research Site
Frankfurt am Main, 60590
GermanySite Not Available
Research Site
Freiburg, 79106
GermanySite Not Available
Research Site
Hannover, 30625
GermanySite Not Available
Research Site
Heidelberg, 69120
GermanySite Not Available
Research Site
Kiel, 24116
GermanySite Not Available
Research Site
Köln, 50937
GermanySite Not Available
Research Site
Leipzig, 04103
GermanySite Not Available
Research Site
München, 81377
GermanySite Not Available
Research Site
Münster, 48149
GermanySite Not Available
Research Site
Tübingen, 72076
GermanySite Not Available
Research Site
Ulm, 89081
GermanySite Not Available
Research Site
Würzburg, 97080
GermanySite Not Available
Research Site
Athens, 11527
GreeceSite Not Available
Research Site
Ioannina, 45110
GreeceSite Not Available
Research Site
Patra, 26500
GreeceSite Not Available
Research Site
Thessaloniki, 57010
GreeceSite Not Available
Research Site
Dublin, 8
IrelandSite Not Available
Research Site
Haifa, 31096
IsraelSite Not Available
Research Site
Jerusalem, 91031
IsraelSite Not Available
Research Site
Petah Tikva, 49100
IsraelSite Not Available
Research Site
Tel Aviv, 64239
IsraelSite Not Available
Research Site
Tel Hashomer, 52621
IsraelSite Not Available
Research Site
Bari, 70124
ItalySite Not Available
Research Site
Bergamo, 24127
ItalySite Not Available
Research Site
Bologna, 40138
ItalySite Not Available
Research Site
Firenze, 50134
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Novara, 28100
ItalySite Not Available
Research Site
Palermo, 90146
ItalySite Not Available
Research Site
Roma, 00133
ItalySite Not Available
Research Site
Torino, 10126
ItalySite Not Available
Research Site
Venezia, 30174
ItalySite Not Available
Research Site
Verona, 37134
ItalySite Not Available
Research Site
Busan, 614-735
Korea, Republic ofSite Not Available
Research Site
Seoul, 110-744
Korea, Republic ofSite Not Available
Research Site
Mexico, Distrito Federal 14000
MexicoSite Not Available
Research Site
Mexico City, Distrito Federal 07760
MexicoSite Not Available
Research Site
Monterrey, Nuevo León 64460
MexicoSite Not Available
Research Site
Lublin, 20-081
PolandSite Not Available
Research Site
Warszawa, 02-776
PolandSite Not Available
Research Site
Wroclaw, 50-367
PolandSite Not Available
Research Site
Moscow, 125167
Russian FederationSite Not Available
Research Site
Nizhny Novgorod, 603126
Russian FederationSite Not Available
Research Site
Petrozavodsk, 185019
Russian FederationSite Not Available
Research Site
Saratov, 410012
Russian FederationSite Not Available
Research Site
Oviedo, Asturias 33011
SpainSite Not Available
Research Site
Salamanca, Castilla León 37007
SpainSite Not Available
Research Site
Badalona, Cataluña 08916
SpainSite Not Available
Research Site
Valencia, Comunidad Valenciana 46026
SpainSite Not Available
Research Site
Madrid, 28041
SpainSite Not Available
Research Site
ChangHua, 50006
TaiwanSite Not Available
Research Site
Taichung, 40447
TaiwanSite Not Available
Research Site
Tainan, 70403
TaiwanSite Not Available
Research Site
Taipei, 10002
TaiwanSite Not Available
Research Site
Adana, 01330
TurkeySite Not Available
Research Site
Ankara, 06100
TurkeySite Not Available
Research Site
Istanbul, 34093
TurkeySite Not Available
Research Site
Izmir, 35340
TurkeySite Not Available
Research Site
Bristol, BS2 8ED
United KingdomSite Not Available
Research Site
London, NW3 2PF
United KingdomSite Not Available
Research Site
Oxford, OX3 7LJ
United KingdomSite Not Available
Research Site
Sheffield, S10 2JF
United KingdomSite Not Available
Research Site
Southampton, SO16 6YD
United KingdomSite Not Available
Research Site
Sutton, SM2 5PT
United KingdomSite Not Available
Research Site
Duarte, California 91010
United StatesSite Not Available
Research Site
Los Angeles, California 90095
United StatesSite Not Available
Research Site
San Francisco, California 94143
United StatesSite Not Available
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Chicago, Illinois 60637
United StatesSite Not Available
Research Site
Baltimore, Maryland 21201
United StatesSite Not Available
Research Site
Boston, Massachusetts 02215
United StatesSite Not Available
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
St Louis, Missouri 63110
United StatesSite Not Available
Research Site
New York, New York 10065
United StatesSite Not Available
Research Site
Durham, North Carolina 27710
United StatesSite Not Available
Research Site
Greenville, South Carolina 29607
United StatesSite Not Available
Research Site
Nashville, Tennessee 37232
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available


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