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Study Complete
Sponsor ID
20130265

Study of Blinatumomab in Japanese Patients with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Sponsor ID
20130265
Clinicaltrials.gov ID
NCT02412306
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
66
Additional Study Details

Protocol Summary

Primary Outcome Measures

Primary Endpoint phase 1= Incidence of DLT (dose limiting toxicities)

Timeframe: Primary outcome will be assessed within 12 weeks of treatment with blinatumomab

Primary Endpoint phase 2 = CR/CRh* within 12 weeks of treatment with blinatumomab

Timeframe: Within 12 weeks of treatment with blinatumomab

Incidence of treatment-emergent and treatment-related adverse events within the Expansion Cohort

Timeframe: 30 (± 3) days after the last dose of IP

Secondary Outcome Measures

Phase 1 the incidence and severity of adverse events

Timeframe: within 12 weeks of blinatumomab treatment

Phase 1 the numer of subjects with complete remission

Timeframe: Within 12 week of treatment with blinatumomab

Phase 1 time to hematological relapse

Timeframe: up to 33 monts

Phase 1 overall survival (OS)

Timeframe: up to 33 months

Phase 1 Relapse free survival (RFS)

Timeframe: up to 33 months

Phase 1 blinatumomab PK parameters

Timeframe: within up to 30 weeks of treatment start

Phase 1 serum cytokine concentrations

Timeframe: within up to 30 weeks of treatment start

Phase 1 incidence of anti-blinatumomab antibody formation

Timeframe: up to 34 weeks after treatment

Phase 2 duration of response (TTHR)

Timeframe: up to 33 months

Phase 2 AlloHSCT after treatment with blinatumomab

Timeframe: up to 33 months

Phase 2 the best overall response

Timeframe: 12 weeks

Phase 2 overall survival

Timeframe: up to 33 months

Phase 2 rate of relapse free survival

Timeframe: up to 33 months

Phase 2 incidence and severity of advese events

Timeframe: up to 33 months

Phase 2 the 100-day mortality after alloHSCT

Timeframe: 100-days

Phase 2 PK parameters

Timeframe: up to 30 weeks

Phase 2 serum cytokine concentrations

Timeframe: up to 30 weeks

Phase 2 anti-blinatumomab antibody formation

Timeframe: up to 34 weeks after treatment start

Phase 1 Duration of CR/CRh*/CRi

Timeframe: up to 33 months

Phase 2 Duration of CR/CRh*/CRi

Timeframe: up to 33 months

CR/CRh* within 12 weeks of treatment with blinatumomab in the Expansion Cohort

Timeframe: Within 12 weeks of treatment with blinatumomab

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Gunmaken Saiseikai Maebashi Hospital
Maebashi-shi, Gunma, Japan, 371-0821
Status
Recruiting
Location
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
Status
Completed
Location
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan, 329-0498
Status
Completed
Location
National Hospital Organization Nagoya Medical Center
Nagoya-shi, Aichi, Japan, 460-0001
Status
Completed
Location
Nagasaki University Hospital
Nagasaki-shi, Nagasaki, Japan, 852-8501
Status
Completed
Location
Kanagawa Childrens Medical Center
Yokohama-shi, Kanagawa, Japan, 232-8555
Status
Completed
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Study Info
Age
0+ years
Condition
  • Leukemia
    • Sex
    All
    Trial Dates
    Jun 2015 - Feb 2019
    Inclusion and Exclusion Criteria
    Adult Subjects Key Inclusion Criteria: • Age ≥ 18 years old at enrollment • 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 Pediatric Subjects Key Inclusion Criteria: • 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: o For subjects in first relapse: failure to achieve a complete response (CR) following a full standard reinduction chemotherapy regimen o 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 Key Exclusion Criteria • Subjects with Burkitt´s Leukemia according to World Health Organization (WHO) classification • 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