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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02910063




Registration number
NCT02910063
Ethics application status
Date submitted
30/08/2016
Date registered
21/09/2016

Titles & IDs
Public title
Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL
Scientific title
A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma
Secondary ID [1] 0 0
2016-002044-16
Secondary ID [2] 0 0
20150292
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-Cell Non Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Blinatumomab

Experimental: Blinatumomab - Blinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab is continuous infusion with step dosing of 9 µg/day x 7 days, 28 µg/day x 7 days, and 112 µg/days until the end of the cycle.


Treatment: Drugs: Blinatumomab
Blinatumomab monotherapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)
Timepoint [1] 0 0
Up to 12 weeks after first dose of blinatumomab
Primary outcome [2] 0 0
Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)
Timepoint [2] 0 0
Up to 12 weeks after first dose of study treatment
Secondary outcome [1] 0 0
Phase 2: Overall Survival (OS)
Timepoint [1] 0 0
From randomization until the end of study, up to 30 months
Secondary outcome [2] 0 0
Phase 2: Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 12 weeks after first dose of blinatumomab
Secondary outcome [3] 0 0
Phase 2: Progression Free Survival (PFS)
Timepoint [3] 0 0
From first dose of blinatumomab until the end of study, up to 30 months
Secondary outcome [4] 0 0
Phase 2: Duration of Response (DOR)
Timepoint [4] 0 0
From first dose of blinatumomab up to 12 weeks
Secondary outcome [5] 0 0
Phase 2: Percentage of Participants Who Experienced Successful Mobilization
Timepoint [5] 0 0
From first dose of blinatumomab until the end of study, up to 30 months
Secondary outcome [6] 0 0
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Timepoint [6] 0 0
From baseline HSCT until the end of study, up to 30 months
Secondary outcome [7] 0 0
Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events
Timepoint [7] 0 0
100 days after HSCT
Secondary outcome [8] 0 0
Phase 2: Blinatumomab Steady State Concentrations (Css)
Timepoint [8] 0 0
Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Secondary outcome [9] 0 0
Phase 2: Blinatumomab Clearance (CL)
Timepoint [9] 0 0
Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Secondary outcome [10] 0 0
Phase 2: Half-life of Blinatumomab
Timepoint [10] 0 0
Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Secondary outcome [11] 0 0
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Timepoint [11] 0 0
From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days
Secondary outcome [12] 0 0
Phase 3: Objective Response Rate (ORR)
Timepoint [12] 0 0
Up to 12 weeks after first dose of study treatment
Secondary outcome [13] 0 0
Phase 3: Progression Free Survival (PFS)
Timepoint [13] 0 0
From first dose of study treatment until the end of study, up to 30 months
Secondary outcome [14] 0 0
Phase 3: Duration of Response (DOR)
Timepoint [14] 0 0
From first dose of study treatment up to 12 weeks
Secondary outcome [15] 0 0
Phase 3: Percentage of Participants Who Experienced Successful Mobilization
Timepoint [15] 0 0
From baseline until the end of study, up to 30 months
Secondary outcome [16] 0 0
Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Timepoint [16] 0 0
From baseline HSCT until the end of study, up to 30 months
Secondary outcome [17] 0 0
Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse
Timepoint [17] 0 0
100 days after HSCT
Secondary outcome [18] 0 0
Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores
Timepoint [18] 0 0
Up to 30 days after last dose after study treatment
Secondary outcome [19] 0 0
Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Timepoint [19] 0 0
From first dose of study treatment until 30 days after last dose
Secondary outcome [20] 0 0
Phase 3: Serum Blinatumomab Steady State Concentration (Css)
Timepoint [20] 0 0
24 hours after first dose of blinatumomab
Secondary outcome [21] 0 0
Phase 3: Blinatumomab Clearance (CL)
Timepoint [21] 0 0
Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Secondary outcome [22] 0 0
Phase 3: Half-life of Blinatumomab
Timepoint [22] 0 0
Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

Eligibility
Key inclusion criteria
* Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:

* Lymphoblastic lymphoma
* Burkitt lymphoma
* Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor.
* Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
* Biopsy proven confirmation of relapsed disease.
* Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
* Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
* Eastern Cooperative Oncology Group performance status less than or equal to 2
* Intention to proceed to high dose chemotherapy (HDT) and autologous hematopoietic stem cell transplant (HSCT)
* Laboratory parameters:

Hematology:

* Absolute neutrophil count (ANC) = 1.0 x 10^9/L
* Platelets = 75 x 10^9/L

Chemistry:

* Creatinine clearance = 50 mL/min
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
* Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* CMR following S1 chemotherapy
* Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
* Prior anti-CD19-directed therapies
* Prior HDT with autologous HSCT
* Prior allogeneic HSCT
* Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
* Evidence of CNS involvement by NHL
* Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti hepatitis C virus positive)
* History of malignancy other than B-NHL within the past 3 years with the exception of:

* Malignancy treated with curative intent and with no known active disease present for = 3 years before enrollment
* Adequately treated non-melanoma skin cancer or lentigo maligna
* Adequately treated cervical carcinoma in situ
* Adequately treated breast ductal carcinoma in situ
* Prostatic intraepithelial neoplasia without evidence of prostate cancer
* Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
* Known sensitivity to immunoglobulins or any of the components to be administered during dosing.
* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed, or of childbearing potential unwilling to use an effective method of contraception while receiving, and for an additional 48 hours after the last dose of blinatumomab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/03/2020
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - St Leonards
Recruitment hospital [2] 0 0
Research Site - Herston
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
South Carolina
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Italy
State/province [9] 0 0
Bergamo
Country [10] 0 0
Italy
State/province [10] 0 0
Firenze
Country [11] 0 0
Italy
State/province [11] 0 0
Genova
Country [12] 0 0
Italy
State/province [12] 0 0
Palermo
Country [13] 0 0
Italy
State/province [13] 0 0
Pisa
Country [14] 0 0
Italy
State/province [14] 0 0
Roma
Country [15] 0 0
Italy
State/province [15] 0 0
Udine
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
San Juan
Country [17] 0 0
Spain
State/province [17] 0 0
Andalucía
Country [18] 0 0
Spain
State/province [18] 0 0
Castilla León
Country [19] 0 0
Spain
State/province [19] 0 0
Cataluña
Country [20] 0 0
Spain
State/province [20] 0 0
Galicia
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Murcia
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Bristol
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Nottingham
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02910063