Conditions: Relapsed Refractory B Precursor Acute Lymphoblastic Leukemia
Keywords: Amgen
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 66
Healthy volunteers: no

Brief summary:
This is an open-label, combined 2-part multicenter study to evaluate the efficacy, safety, and tolerability of blinatumomab in adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL.

Detailed description:
The Phase 1b part will investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of blinatumomab to determine the maximum tolerated dose (MTD) in both adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL. The Phase 2 part will assess the safety and efficacy of the recommended dose level of blinatumomab identified in the Phase 1b portion of the study in the adult study population.

In June 2017 protocol amendment 4 extended the study to include an expansion cohort of approximately 65 participants to investigate the safety of blinatumomab in participants who did not participate in Phase 1b or Phase 2 of the study. Adult and pediatric patients in the expansion cohort may receive up to 5 cycles of investigational blinatomumab and may receive commercial blinatomumab after a minimum of 2 cycles of the investigational drug.

Arms:
arm 1: Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose for adults was 9 µg/day for the first week of cycle 1, escalated to 28 µg/day starting from Week 2 and all cycles thereafter. arm 2: Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. For pediatric participants the initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter. arm 3: Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose for adults was 9 µg/day for the first week of cycle 1, escalated to 28 µg/day starting from Week 2 and all cycles thereafter. arm 4: Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose for adults was 9 µg/day for the first week of cycle 1, escalated to 28 µg/day starting from Week 2 and all cycles thereafter. arm 5: Participants received blinatumomab by CIV infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. For pediatric participants the initial dose was 5 µg/m²/day for the first week of cycle 1, escalated to 15 µg/m²/day starting from week 2 and all cycles thereafter.

Interventions: intervention 1: Blinatumomab
Intervention descriptions: intervention 1: Continuous intravenous infusion over four weeks per treatment cycle

Protocol document:
Prot_000.pdf: 
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Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  20 March 2019 
Page 1 of 5 
CONFIDENTIAL 
 
 
Amendment 5 
Protocol Title:  A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With 
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) 
(Horai Study) 
 
Amgen Protocol Number (Blinatumomab) 20130265 
NCT Number:  NCT02412306 
 
Amendment Date: 
20 March 2019 
 
Rationale: 
This protocol is being amended to: 
• 
Update the Primary Completion and End of Study language to reflect end of 
evaluation in the expansion cohort instead of Phase 1b/2 portion of study. 
• 
Revise the analysis set to include expansion cohort. 
• 
Align that the final analysis occurs when the last subject in the expansion cohort 
finishes safety follow-up period. 
• 
Remove language regarding self-evident corrections in Section 12.3 which has been 
retired by Amgen.   


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Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  20 March 2019 
Page 4 of 5 
CONFIDENTIAL 
 
 
Section:  3.5.2 End of Study, Paragraphs 2-4 
Replace: 
Primary Completion:  the time when the last subject is assessed or receives an 
intervention for the purposes of final collection of data for the primary endpoint for the 
purposes of conducting the primary analysis, whether the study concluded as planned or 
was terminated early (see Section10.3.4). 
End of Trial:  Phase 1b/2: the time when the last subject is assessed or receives an 
intervention for evaluation in the study (see Section 10.3.5), which corresponds to the 
24 month long-term follow-up visit. 
Expansion cohort: The expansion cohort will close when the drug is commercially 
available in Japan and the expansion  part of the study will end when the last subject 
enrolled has completed at least 2 cycles of blinatumomaband safety follow-up.   
With: 
Primary Completion:  The primary completion date is defined as the date when the 
last subject is assessed or receives an intervention for the final collection of data for the 
primary endpoint(s), whether the study concluded as planned or was terminated early 
(see Section 10.3.4). 
End of Study:  Phase 1b/2:  The end of study date is defined as the date when the 
last subject across all sites is assessed or receives an intervention for evaluation in the 
study (see Section 10.3.5), which corresponds to the 24 month long-term follow-up visit. 
Expansion cohort:  The expansion cohort will close when the drug is commercially 
available in Japan and the expansion portion of the study will end when the last subject 
enrolled has completed at least 2 cycles of blinatumomab and safety follow-up.   
Section:  10.1.2 Analysis Sets, Paragraph 1 
Add: 
The statistical analysis will be based on the following study populations:  Phase 1b (dose 
evaluation), Phase 2 (efficacy), expansion cohort, and pooled analysis sets.  Adult 
subjects and pediatric subjects will be summarized separately. 


Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  20 March 2019 
Page 5 of 5 
CONFIDENTIAL 
 
 
Section:  10.3.5 Final Analysis, Paragraph 1 
Add: 
The objective of the final analysis is to update the following secondary and exploratory 
endpoints for Phase 1b/2 cohort with further follow-up data:  RFS, OS, 100-day 
mortality after alloHSCT, incidence of adverse events, and incidence of antibody 
formation, and analyze the expansion cohort.  A final analysis will be conducted when 
all enrolled subjects in Phase 1b/2 complete the long-term follow-up period of the 
protocol, and all enrolled subjects in the expansion cohort complete the safety 
follow-up period. 
Section:  12.3 Study Monitoring and Data Collection, Paragraph 6 
Delete: 
Amgen (or designee) will perform self-evident corrections (SECs) to obvious data errors 
in the clinical trial database.  SECs will be documented in the eCRF instructions 
available in the EDC system.  Examples of obvious data errors that may be corrected by 
Amgen (or designee) include deletion of obvious duplicate data (ie, the same results 
sent twice with the same date with different visit, [eg, week 4 and early termination]) and 
updating specific response if the confirming datum is provided in the “other, specify” field 
(eg, for race, reason for ending study). 


Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  04 August 2017 
Page 1 of 4 
CONFIDENTIAL 
 
 
Superseding Amendment 4 
Protocol Title:  A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With 
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) 
(Horai Study) 
 
Amgen Protocol Number  20130265 
 
Amendment Date: 
04 August 2017 
Rationale: 
This protocol is being to amended help clarify issues that were identified after finalization 
of Amendment 4.  Changes include: 
• 
Added ClinicalTrials.gov Identifier as it is a requirement to disclose Japan (or other 
single ex-US) studies that meet the definition of Applicable Clinical Trials for 
ClinicalTrials.gov 
• 
Added amendment approval date 
• 
Corrected units in the dosing box in the expansion cohort section of the Pediatric 
Subjects Schema 
• 
Clarified the number of subjects in the expansion cohort 
• 
Clarified expansion cohort dosing for the adult subjects 
• 
Added information on expansion cohort dosing for pediatric subjects 
• 
Clarified study phase in Schedule of Assessments title 
• 
Deleted definition of CRi from Appendix F as it is not appropriate for this study 
• 
Minor administrative and editorial changes 


Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  23 May 2016 
Page 1 of 27 
CONFIDENTIAL 
 
 
Amendment 3 
Protocol Title:  A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With 
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) 
(Horai Study) 
 
Amgen Protocol Number 20130265 
EudraCT number N/A 
 
Amendment Date: 
23 May 2016 
Rationale: 
This protocol is being amended to: 
• 
Update and clarify the dexamethasone premedication dosing 
• 
Inclusion and exclusion criteria were updated: 
o Update pediatric inclusion to clarify definition of relapsed/refractory 
disease. 
o Pediatric subject inclusion was updated to remove eligibility that subjects 
previously treated with blinatumomab may be eligible to align with adult 
criteria. 
o Pediatric inclusion updated to clarify blasts in bone marrow can be 
greater than 5% to align with adult criteria. 
• 
Update the contraception and pregnancy language to reflect the newest protocol 
template (including the inclusion and exclusion criteria). 
• 
The capture of Disease Related Events (DRE) was removed from the protocol. 
This was added at amendment 1 as a result of protocol template change, 
however, it was not required. No CRFs or SAPs were updated when DREs were 
added to the protocol; therefore, they have been removed. 
• 
The definition of complete remission with incomplete hematological recovery was 
removed from the protocol to align with the new SAP amendment. 
• 
Covariate and Subgroup for ‘Age’ was corrected 
• 
Protocol was updated to align with current version of protocol template: 
o Section 9.1.1 Definition of Adverse Event 
o Section 9.2.2 Reporting Procedures for Serious Adverse Events 
o Section 11.1 Informed Consent 
o Section 12 Administrative and Legal Obligations 
• 
Appendix C and Appendix D were corrected 


Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  07 March 2016 
Page 1 of 31 
CONFIDENTIAL 
 
 
Amendment 2 
Protocol Title:  A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With 
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)  
(Horai Study) 
 
Amgen Protocol Number 20130265 
EudraCT number N/A 
 
Amendment Date: 
07 March 2016 
Rationale: 
This protocol is being amended to: 
• 
Update and clarify the dexamethasone premedication dosing 
• 
Appendix H was updated to reflect the latest IB 
• 
Inclusion and exclusion criteria were updated: 
o Remove inclusion criteria that required the disease to be measurable 
in case of extramedullary disease in addition to medullary disease 
o Pediatric subject inclusion criteria regarding percentage of blasts in 
bone marrow was updated 
o Exclusion criteria for creatinine updated to include criteria for 
creatinine clearance 
• 
Update the contraception and pregnancy language 
• 
Secondary Endpoints were updated to align with the current blinatumomab 
program 
• 
One additional subgroup covariate was added 
• 
Subject writing sample removed during screening phase 
• 
Time-sensitive PK samples were clarified 
• 
Appendix B, Appendix C, Appendix D, and Appendix K were all updated 
• 
Table 5 was updated to clarify dose modifications 
• 
Section 10.3.1 was updated to clarify what is meant by stage 1 and 2 


Product:  Blinatumomab 
Protocol Number:  20130265 
Date:  02 November 2015 
Page 1 of 70 
CONFIDENTIAL 
 
 
Amendment 1 
Protocol Title:  A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With 
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) 
(Horai Study) 
 
Amgen Protocol Number 20130265 
 
Version 1.0; Date 
Amendment Date: 
24 November 2014 
02 November 2015 
Rationale: 
This protocol amendment was created to add Pediatric cohorts (dose de-escalation 
design) in Phase 1b in hopes to be able to file in Japan in a pediatric setting. 

SAP_001.pdf: 
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