Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
NCT ID: NCT02412306
Last Updated: 2022-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2015-06-04
2019-07-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Blinatumomab 9-28 µg/day Phase 1b Adult Population
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.
Blinatumomab
Continuous intravenous infusion over four weeks per treatment cycle
Blinatumomab 5-15 µg/m^2/day Phase 1b Pediatric Population
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.
Blinatumomab
Continuous intravenous infusion over four weeks per treatment cycle
Blinatumomab 9-28 µg/day Phase 2 Adult Population
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.
Blinatumomab
Continuous intravenous infusion over four weeks per treatment cycle
Blinatumomab 9-28 µg/day Adult Expansion Population
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.
Blinatumomab
Continuous intravenous infusion over four weeks per treatment cycle
Blinatumomab 5-15 µg/m^2/day Pediatric Expansion Population
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.
Blinatumomab
Continuous intravenous infusion over four weeks per treatment cycle
Interventions
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Blinatumomab
Continuous intravenous infusion over four weeks per treatment cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with Philadelphia-negative B-precursor ALL, with any of the following:
* Relapsed or refractory after first line therapy with first remission duration ≤ 12 months; or
* Relapsed or refractory after first salvage therapy; or
* Relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplant (alloHSCT)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
* Greater than 5% blasts in bone marrow
* Age \< 18 years old at enrollment
* Relapsed/refractory disease, defined as one of the following:
* second or later bone marrow relapse;
* any marrow relapse after alloHSCT; or
* Refractory to other treatments:
* For subjects in first relapse: failure to achieve a complete response (CR) following a full standard reinduction chemotherapy regimen
* For subjects who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
* Greater than 5% blasts in bone marrow
* Karnofsky performance status ≥ 50% for subjects ≥ 16 years
* Lansky performance status ≥ 50% for subjects \< 16 years
Exclusion Criteria
* History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis; with the exception of well-controlled CNS leukemia
* Active ALL in the CNS or testes
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Autologous HSCT within 6 weeks prior to start of blinatumomab treatment
* AlloHSCT within 12 weeks prior to start of blinatumomab treatment
* Any active acute Graft-versus-Host Disease (GvHD) grade 2-4 according to Glucksberg criteria or active chronic GvHD requiring systemic treatment
0 Years
ALL
No
Sponsors
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Amgen Astellas Biopharma K.K.
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Gunma, Japan
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kanagawa Childrens Medical Center
Yokohama, Kanagawa, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka City General Hospital
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Saitama Childrens Medical Center
Saitama-shi, Saitama, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Countries
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References
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Horibe K, Morris JD, Tuglus CA, Dos Santos C, Kalabus J, Anderson A, Goto H, Ogawa C. A phase 1b study of blinatumomab in Japanese children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Int J Hematol. 2020 Aug;112(2):223-233. doi: 10.1007/s12185-020-02907-9. Epub 2020 Jun 20.
Kiyoi H, Morris JD, Oh I, Maeda Y, Minami H, Miyamoto T, Sakura T, Iida H, Tuglus CA, Chen Y, Dos Santos C, Kalabus J, Anderson A, Hata T, Nakashima Y, Kobayashi Y. Phase 1b/2 study of blinatumomab in Japanese adults with relapsed/refractory acute lymphoblastic leukemia. Cancer Sci. 2020 Apr;111(4):1314-1323. doi: 10.1111/cas.14322. Epub 2020 Feb 11.
Kobayashi Y, Oh I, Miyamoto T, Lee WS, Iida H, Minami H, Maeda Y, Jang JH, Yoon SS, Yeh SP, Tran Q, Morris J, Franklin J, Kiyoi H. Efficacy and safety of blinatumomab: Post hoc pooled analysis in Asian adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Asia Pac J Clin Oncol. 2022 Jun;18(3):311-318. doi: 10.1111/ajco.13609. Epub 2021 Jun 29.
Goto H, Ogawa C, Iida H, Horibe K, Oh I, Takada S, Maeda Y, Minami H, Nakashima Y, Morris JD, Kormany W, Chen Y, Miyamoto T. Safety and Efficacy of Blinatumomab in Japanese Adult and Pediatric Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Final Results from an Expansion Cohort. Acta Haematol. 2022;145(6):592-602. doi: 10.1159/000525835. Epub 2022 Jul 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20130265
Identifier Type: -
Identifier Source: org_study_id