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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04524455




Registration number
NCT04524455
Ethics application status
Date submitted
20/08/2020
Date registered
24/08/2020

Titles & IDs
Public title
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
Scientific title
A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Secondary ID [1] 0 0
20190177
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Blinatumomab
Treatment: Drugs - AMG 404
Treatment: Drugs - Dexamethasone Premedication

Experimental: Blinatumomab and AMG 404 -


Treatment: Drugs: Blinatumomab
Blinatumomab will be administered as a continuous intravenous infusion (cIV).

Treatment: Drugs: AMG 404
AMG 404 will be administered as an intravenous infusion (IV).

Treatment: Drugs: Dexamethasone Premedication
Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Cohort 1: Up to 67 days; Cohort 2a: Up to 56 days
Primary outcome [2] 0 0
Number of Participants Who Experienced Treatment-Emergent AEs (TEAEs)
Timepoint [2] 0 0
Median (min, max) overall duration from first dose until 30 days after last dose is: 83.4 (40.2, 274.1) days
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Complete Remission (CR) or CR With Partial Hematological Recovery (CRh) (CR/CRh)
Timepoint [1] 0 0
Within the first 2 cycles: Up to approximately 86 days; across all cycles: Up to approximately 274 days
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved CR
Timepoint [2] 0 0
Within the first 2 cycles: Up to approximately 86 days; across all cycles: Up to approximately 274 days
Secondary outcome [3] 0 0
Median Duration of CR in Participants Who Achieved CR Within First 2 Cycles
Timepoint [3] 0 0
Up to approximately 274 days
Secondary outcome [4] 0 0
Median Duration of CR/CRh in Participants Who Achieved CR/CRh Within First 2 Cycles
Timepoint [4] 0 0
Up to approximately 274 days
Secondary outcome [5] 0 0
Steady-state Concentrations (Css) of Blinatumomab
Timepoint [5] 0 0
Cohort 1: C1D1 and D8 (predose, 2 to 24 h postdose), and D11, D18 and D29; C2D1 (predose, 2 to 24 h postdose) and D29. Cohort 2a: C1D3 and D10 (predose, 2 to 48 h postdose), and D29, D30 and D31; C2D1 (predose, 2 to 24 h postdose), D13 and D29
Secondary outcome [6] 0 0
Maximum Observed Concentration (Cmax) of AMG 404
Timepoint [6] 0 0
Cohort 1: C1D11 (predose, end of infusion to 48 h postdose), D18, D29, and D39 (predose and end of infusion). Cohort 2a: C1D1 (predose, end of infusion to 168 h postdose), D12 and D29 (predose and end of infusion)
Secondary outcome [7] 0 0
Time to Cmax (Tmax) of AMG 404
Timepoint [7] 0 0
Cohort 1: C1D11 (predose, end of infusion to 48 h postdose), D18, D29, and D39 (predose and end of infusion). Cohort 2a: C1D1 (predose, end of infusion to 168 h postdose), D12 and D29 (predose and end of infusion)
Secondary outcome [8] 0 0
Area Under the Plasma Concentration-time Curve From Time 0 to 28 Days Post Infusion (AUC0-28d) of AMG 404
Timepoint [8] 0 0
Cohort 1: C1D11 (predose, end of infusion to 48 h postdose), D18, D29, and D39 (predose and end of infusion). Cohort 2a: C1D1 (predose, end of infusion to 168 h postdose), D12 and D29 (predose and end of infusion)
Secondary outcome [9] 0 0
Number of Participants With Incidences of Anti-Blinatumomab Antibodies
Timepoint [9] 0 0
Up to approximately 274 days
Secondary outcome [10] 0 0
Number of Participants With Incidences of Anti-AMG 404 Antibodies
Timepoint [10] 0 0
Up to approximately 274 days

Eligibility
Key inclusion criteria
Inclusion Criteria

* Age = 18 years at enrollment.
* Greater than or equal to 5% blasts in the bone marrow.
* Eastern Cooperative Oncology Group performance status (ECOG PS) = 2.
* Negative pregnancy test in women of childbearing potential.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
* Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 1
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
2/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/01/2023
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
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
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Austria
State/province [6] 0 0
Linz
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Pierre Benite
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt am Main
Country [10] 0 0
Germany
State/province [10] 0 0
Kiel
Country [11] 0 0
Germany
State/province [11] 0 0
Regensburg
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Italy
State/province [13] 0 0
Brescia
Country [14] 0 0
Netherlands
State/province [14] 0 0
Groningen
Country [15] 0 0
Spain
State/province [15] 0 0
Cataluña
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL 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/NCT04524455