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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04524455
Ethics application status
Date submitted
20/08/2020
Date registered
24/08/2020
Date last updated
11/03/2021

Titles & IDs
Public title
A Study of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Acute Lymphoblastic Leukemia (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 Experience Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to 8 Weeks
Primary outcome [2] 0 0
Number of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to 51 Weeks
Primary outcome [3] 0 0
Number of Participants who Experience Serious Treatment-Emergent Adverse Events
Timepoint [3] 0 0
Up to 51 Weeks
Primary outcome [4] 0 0
Number of Participants who Experience Treatment-Related Treatment-Emergent Adverse Events
Timepoint [4] 0 0
Up to 51 Weeks
Primary outcome [5] 0 0
Number of Participants who Experience Adverse Events of Special Interest (AESI)
Timepoint [5] 0 0
Up to 51 Weeks
Secondary outcome [1] 0 0
Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*)
Timepoint [1] 0 0
Up to 51 Weeks
Secondary outcome [2] 0 0
Complete Remission (CR) Rate
Timepoint [2] 0 0
Up to 51 Weeks
Secondary outcome [3] 0 0
Duration of Complete Remission (CR)
Timepoint [3] 0 0
Up to 51 Weeks
Secondary outcome [4] 0 0
Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*)
Timepoint [4] 0 0
Up to 51 Weeks
Secondary outcome [5] 0 0
Steady State Concentrations (Css) of Blinatumomab
Timepoint [5] 0 0
Up to 35 Weeks
Secondary outcome [6] 0 0
Maximum Observed Concentration (Cmax) of AMG 404
Timepoint [6] 0 0
Up to 51 Weeks
Secondary outcome [7] 0 0
Time to Maximum Observed Concentration (Tmax) of AMG 404
Timepoint [7] 0 0
Up to 51 Weeks
Secondary outcome [8] 0 0
Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404
Timepoint [8] 0 0
Up to 51 Weeks
Secondary outcome [9] 0 0
Number of Participants with Incidences of Anti-Blinatumomab Antibodies
Timepoint [9] 0 0
Up to 35 Weeks
Secondary outcome [10] 0 0
Number of Participants with Incidences of Anti-AMG 404 Antibodies
Timepoint [10] 0 0
Up to 35 Weeks

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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted
therapy) within 21 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
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - 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
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Pierre-Benite
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt am Main
Country [9] 0 0
Germany
State/province [9] 0 0
Kiel
Country [10] 0 0
Italy
State/province [10] 0 0
Brescia
Country [11] 0 0
Netherlands
State/province [11] 0 0
Groningen
Country [12] 0 0
Spain
State/province [12] 0 0
Cataluña

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are to evaluate the safety and tolerability of
blinatumomab in combination with AMG 404 in adults with acute lymphoblastic leukemia (ALL)
and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG
404 when combined with continuous intravenous infusion (cIV) blinatumomab.
Trial website
https://clinicaltrials.gov/show/NCT04524455
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
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04524455