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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02393859
Registration number
NCT02393859
Ethics application status
Date submitted
16/03/2015
Date registered
20/03/2015
Date last updated
29/05/2024
Titles & IDs
Public title
Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
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Scientific title
Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL
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Secondary ID [1]
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2014-002476-92
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Secondary ID [2]
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20120215
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Acute Lymphoblastic
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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0
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Children's - Leukaemia & Lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Blinatumomab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Vincrisitne
Treatment: Drugs - Daunorubicin
Treatment: Drugs - Methotrexate
Treatment: Drugs - Ifosfamide
Treatment: Drugs - PEG-asparaginase
Treatment: Drugs - Erwinia-asparaginase
Active Comparator: High Risk Consolidation 3 (HC3) Chemotherapy - One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day intravenous [IV] on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or intramuscularly [IM] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
Experimental: Blinatumomab - 15 µg/m^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
Treatment: Drugs: Blinatumomab
15 µg/m^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
Treatment: Drugs: Dexamethasone
10 mg/m^2/day intravenous (IV) on Days 1-6
Treatment: Drugs: Vincrisitne
1.5 mg/m^2/day IV on Days 1 and 6
Treatment: Drugs: Daunorubicin
30 mg/m^2 IV over 24 hours on Day 5
Treatment: Drugs: Methotrexate
1 g/m^2 IV over 36 hours on Day 1
Treatment: Drugs: Ifosfamide
800 mg/m^2 IV for 1 hour on Days 2-4
Treatment: Drugs: PEG-asparaginase
1000 U/m^2 IV for 2 hours or intramuscularly (IM) on Day 6
Treatment: Drugs: Erwinia-asparaginase
In case of allergic reaction to PEG-asparaginase, participants could change to erwinia-asparaginase, 20,000 units/m2 every 48 hours for a total of 6 doses
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis)
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Assessment method [1]
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EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with = 5% and < 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date.
Participants were said to be in CR when they had the following:
M1 marrow
Peripheral blood without blasts
Absence of extramedullary leukemic involvement
Months are calculated as days from randomization date to event/censor date, divided by 30.5.
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Timepoint [1]
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As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months.
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Primary outcome [2]
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Kaplan Meier Estimate: EFS (Final Analysis)
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Assessment method [2]
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EFS is calculated from the time of randomization until the date of relapse or M2 marrow after having achieved a CR, failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with IP or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date.
Participants were said to be in CR when they had the following:
M1 marrow
Peripheral blood without blasts
Absence of extramedullary leukemic involvement
Months are calculated as days from randomization date to event/censor date, divided by 30.5.
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Timepoint [2]
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At final analysis, overall median follow-up time for EFS was 51.9 months.
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Secondary outcome [1]
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Kaplan Meier Estimate: Overall Survival (OS)
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Assessment method [1]
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OS was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.
Months were calculated as days from randomization date to event/censor date, divided by 30.5.
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Timepoint [1]
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At final analysis, overall median follow-up time for OS was 55.2 months.
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Secondary outcome [2]
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Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation
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Assessment method [2]
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At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.
MRD response was defined as MRD level < 10^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.
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Timepoint [2]
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Up to End of Treatment (Cycle 1, Day 29)
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Secondary outcome [3]
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Cumulative Incidence of Relapse (CIR)
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Assessment method [3]
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CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up.
Relapse=presence of =1 of the following:
isolated bone marrow relapse (M3 marrow [representative bone marrow aspirate or biopsy with =25% blasts] in the absence of extramedullary involvement)
combined bone marrow relapse (M2 [representative bone marrow aspirate or biopsy with =5% and <25% blasts] or M3 marrow and =1 extramedullary manifestation of acute lymphoblastic leukemia)
central nervous system extramedullary relapse
testicular extramedullary relapse
extramedullary relapse at other sites
Months were calculated as days from randomization to event/censor date, divided by 30.5.
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Timepoint [3]
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At final analysis, the overall maximum follow-up time was 82.0 months.
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Secondary outcome [4]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
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Assessment method [4]
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Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.
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Timepoint [4]
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From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
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Secondary outcome [5]
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Number of Participants With TEAEs of Interest
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Assessment method [5]
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TEAEs of interest included capillary leak syndrome (CLS), cytokine release syndrome (CRS), decreased immunoglobulins (DI), elevated liver enzymes (ELE), embolic and thrombotic events (ETE), infections (INF), infusion reactions without considering duration (IRWCD), medication errors (ME), neurologic events (NE), neutropenia and febrile neutropenia (NFN), pancreatitis (PNC), tumor lysis syndrome, leukoencephalopathy, immunogenicity. Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
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Timepoint [5]
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From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
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Secondary outcome [6]
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Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values
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Assessment method [6]
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Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (?) or decreases (?) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (? PB) grade are presented. NA=not available.
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Timepoint [6]
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Up to Day 29 (± 2 days).
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Secondary outcome [7]
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Kaplan-Meier Estimate of 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
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Assessment method [7]
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The analysis of 100-day mortality after alloHSCT was assessed for participants who received an alloHSCT while in remission and did not receive any additional anti-leukemic treatment. 100-day mortality after alloHSCT was calculated relative to the date of alloHSCT.
The 100-day mortality rate after alloHSCT was defined as the percentage of participants having died up to 100 days after alloHSCT, estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants still alive were censored at the date they were last known to be alive.
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Timepoint [7]
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From the date of alloHSCT until death/censor date; median follow up time was 1742.0 days for blinatumomab and 1619.0 days for HC3.
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Secondary outcome [8]
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Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only)
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Assessment method [8]
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Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies.
Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented.
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Timepoint [8]
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Day 1 to Day 29.
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Secondary outcome [9]
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Pharmacokinetics: Concentration at Steady State (Css) (Blinatumomab Arm Only)
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Assessment method [9]
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Timepoint [9]
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Day 1: at least 10 hours after infusion start and up to 24 hours; Day 15
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Secondary outcome [10]
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Pharmacokinetics: Clearance (CL) (Blinatumomab Arm Only)
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Assessment method [10]
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Timepoint [10]
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Day 1: at least 10 hours after infusion start and up to 24 hours; Day 15
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Eligibility
Key inclusion criteria
- Subjects with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse
B-precursor acute lymphoblastic leukemia (ALL; as defined by International
Berlin-Frankfurt-Muenster study group/International study for treatment of childhood
relapsed ALL [I-BFM SG/IntReALL] criteria)
- Subjects with bone marrow blast percentage < 5% (M1) or bone marrow blast percentage <
25% and =5% (M2) marrow at the time of randomization,
- Age > 28 days and < 18 years at the time of informed consent/assent
- Subject's legally acceptable representative has provided informed consent when the
subject is legally too young to provide informed consent and the subject has provided
written assent based on local regulations and/or guidelines prior to any
study-specific activities/procedures being initiated
- Availability of the following material from relapse diagnosis for central analysis of
minimal residual disease (MRD) by polymerase chain reaction (PCR): clone-specific
primers and reference deoxyribonucleic acid (DNA), as well as primer sequences and
analyzed sequences of clonal rearrangements (cases with isolated extramedullary
relapse or cases with technical and/or logistic hurdles to obtain and process bone
marrow material are exempt from providing this material. In these cases, central MRD
analysis only by Flow is permitted).
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Minimum age
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Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinically relevant central nervous system (CNS) pathology requiring treatment (eg,
unstable epilepsy). Evidence of current CNS (CNS 2, CNS 3) involvement by ALL.
Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully
treated prior to enrollment
- Peripheral neutrophils < 500/µL prior to start of treatment
- Peripheral platelets < 50,000/µL prior to start of treatment
- Currently receiving treatment in another investigational device or drug study or less
than 4 weeks since ending treatment on another investigational device or drug
study(s), procedures required by IntReALL high-risk (HR) guidelines are allowed
- Chemotherapy related toxicities that have not resolved to = grade 2 (except for
parameters defined in Exclusion Criteria 202, 203, 204, and 217)
- Symptoms and/or clinical signs and/or radiological and/or sonographic signs that
indicate an acute or uncontrolled chronic infection, any other concurrent disease or
medical condition that could be exacerbated by the treatment or would seriously
complicate compliance with the protocol
- Abnormal renal or hepatic function prior to start of treatment (day 1) as defined
below
- Abnormal serum creatinine based on age/gender
- Total bilirubin > 3.0 mg/dL prior to start of treatment (unless related to Gilbert's
or Meulengracht disease)
- Documented infection with human immunodeficiency virus (HIV)
- Known hypersensitivity to immunoglobulins or any of the products or components to be
administered during dosing (excluding asparaginase)
- Post-menarchal female subject who is pregnant or breastfeeding, or is planning to
become pregnant or breastfeed while receiving protocol-specified therapy and for at
least 12 months after the last dose of chemotherapy
- Post-menarchal female subject who is not willing to practice true sexual abstinence or
use a highly effective form of contraception while receiving protocol-specified
therapy and for at least 12 months after the last dose of chemotherapy
- Sexually mature male subject who is not willing to practice true sexual abstinence or
use a condom with spermicide while receiving protocol-specified therapy and for at
least 6 months after last dose of chemotherapy. In countries where spermicide is not
available, a condom without spermicide is acceptable
- Sexually mature male subject who is not willing to abstain from sperm donation while
receiving protocol-specified therapy and for at least 6 months after last dose of
chemotherapy
- Subject likely to not be available to complete all protocol-required study visits or
procedures, including follow-up visits, and/or to comply with all required study
procedures to the best of the subject's and investigator's knowledge
- History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) that, in the opinion of the investigator
or Amgen physician, if consulted, would pose a risk to subject safety or interfere
with the study evaluation, procedures, or completion
- Placed into an institution due to juridical or regulatory ruling.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/11/2022
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Sample size
Target
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Accrual to date
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Final
111
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Research Site - Randwick
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Recruitment hospital [2]
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Research Site - Westmead
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Recruitment hospital [3]
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Research Site - South Brisbane
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Recruitment hospital [4]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Paraná
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Czechia
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Praha 5
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Denmark
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Kobenhavn O
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France
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Bordeaux Cedex
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France
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Lille
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France
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Lyon
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France
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Marseille cedex 5
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France
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Montpellier cedex 05
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France
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Nantes cedex 1
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France
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Paris
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Strasbourg Cedex
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France
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Vandoeuvre les Nancy
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Germany
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Berlin
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Germany
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Duesseldorf
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Freiburg
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Giessen
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Hamburg
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Germany
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Hannover
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Jena
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Kiel
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München
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Germany
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Münster
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Germany
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Tübingen
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Ulm
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Würzburg
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Greece
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Goudi
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Bologna
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Italy
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Napoli
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Italy
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Padova
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Italy
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Pavia
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Italy
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Roma
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Italy
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Torino
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Netherlands
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Rotterdam
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Utrecht
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Norway
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Oslo
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Bydgoszcz
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Poland
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Funding & Sponsors
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Commercial sector/Industry
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Amgen
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Summary
Brief summary
B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according
to risk characteristics to ensure that appropriate treatment is administered to patients with
high-risk of relapse. In general, pediatric treatment regimens are more intense than those
employed in adults and include courses of combination chemotherapy. Standard of care
chemotherapy is associated with considerable toxicity. There is a lack of novel treatment
options for subjects who relapse or are refractory to treatment. Therefore, innovative
therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain
antibody construct designed to link B cells and T cells resulting in T cell activation and a
cytotoxic T cell response against CD19 expressing cells. This study will evaluate the
event-free survival (EFS) after treatment with blinatumomab when compared to standard of care
(SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal
residual disease compared to SOC chemotherapy will also be investigated.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02393859
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Trial related presentations / publications
Locatelli F, Eckert C, Hrusak O, Buldini B, Sartor M, Zugmaier G, Zeng Y, Pilankar D, Morris J, von Stackelberg A. Blinatumomab overcomes poor prognostic impact of measurable residual disease in pediatric high-risk first relapse B-cell precursor acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Aug;69(8):e29715. doi: 10.1002/pbc.29715. Epub 2022 Apr 28.
Blinatumomabe em pacientes pediátricos com leucemia linfoblástica aguda B em primeira recidiva de alto risco: um estudo de custo-efetividade. van Beurden-Tan CHY, Ribeiro RA, Seber A, de Martino Lee ML, Marçola M, Schuetz R, Loggetto SR, Maiolino A. Jornal Brasileiro de Economia da Saúde 14(1): 41-50. 10.21115/JBES.v14.n1.p41-50
Locatelli F, Zugmaier G, Rizzari C, Morris JD, Gruhn B, Klingebiel T, Parasole R, Linderkamp C, Flotho C, Petit A, Micalizzi C, Mergen N, Mohammad A, Kormany WN, Eckert C, Moricke A, Sartor M, Hrusak O, Peters C, Saha V, Vinti L, von Stackelberg A. Effect of Blinatumomab vs Chemotherapy on Event-Free Survival Among Children With High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2021 Mar 2;325(9):843-854. doi: 10.1001/jama.2021.0987.
Caillon M, Brethon B, van Beurden-Tan C, Supiot R, Le Mezo A, Chauny JV, Majer I, Petit A. Cost-Effectiveness of Blinatumomab in Pediatric Patients with High-Risk First-Relapse B-Cell Precursor Acute Lymphoblastic Leukemia in France. Pharmacoecon Open. 2023 Jul;7(4):639-653. doi: 10.1007/s41669-023-00411-4. Epub 2023 Apr 18.
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Public notes
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Contacts
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02393859
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