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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04994717




Registration number
NCT04994717
Ethics application status
Date submitted
30/07/2021
Date registered
6/08/2021

Titles & IDs
Public title
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Scientific title
Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
Secondary ID [1] 0 0
2023-503640-14
Secondary ID [2] 0 0
20190360
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) 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 - Low-intensity chemotherapy regimen
Treatment: Drugs - SOC chemotherapy regimen

Experimental: Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy - The safety run-in will be performed prior to initiating the phase 3 randomized part of the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.

The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion.

Experimental: Phase 3: Blinatumomab alternating with low-intensity chemotherapy - Participants will receive blinatumomab alternating with low-intensity chemotherapy.

Active comparator: Phase 3: Standard of care (SOC) chemotherapy - Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.


Treatment: Drugs: Blinatumomab
Continuous intravenous (cIV) infusion

Treatment: Drugs: Low-intensity chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

Treatment: Drugs: SOC chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Phase 3: Event-free Survival (EFS)
Timepoint [2] 0 0
Up to approximately 5 years
Primary outcome [3] 0 0
Phase 3: Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Timepoint [1] 0 0
Baseline to Week 14
Secondary outcome [2] 0 0
Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
Timepoint [2] 0 0
Baseline to Week 14
Secondary outcome [3] 0 0
Safety run-in: Relapse-free Survival (RFS)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Safety run-in: Steady State Concentration (Css) of Blinatumomab
Timepoint [5] 0 0
Up to approximately 34 weeks
Secondary outcome [6] 0 0
Safety run-in: Clearance (CL) of Blinatumomab
Timepoint [6] 0 0
Up to approximately 34 weeks
Secondary outcome [7] 0 0
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score
Timepoint [7] 0 0
Baseline to Week 14
Secondary outcome [8] 0 0
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score
Timepoint [8] 0 0
Baseline to Week 14
Secondary outcome [9] 0 0
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status
Timepoint [9] 0 0
Baseline to Week 14
Secondary outcome [10] 0 0
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function
Timepoint [10] 0 0
Baseline to Week 14
Secondary outcome [11] 0 0
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting
Timepoint [11] 0 0
Baseline to Week 14
Secondary outcome [12] 0 0
Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Timepoint [12] 0 0
Baseline to Week 14
Secondary outcome [13] 0 0
Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
Timepoint [13] 0 0
Baseline to Week 14
Secondary outcome [14] 0 0
Phase 3: Relapse-free Survival (RFS)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
Timepoint [15] 0 0
Up to approximately 5 years
Secondary outcome [16] 0 0
Phase 3: Minimal Residual Disease (MRD) Over Time
Timepoint [16] 0 0
Up to approximately 5 years
Secondary outcome [17] 0 0
Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Timepoint [17] 0 0
Up to approximately 5 years
Secondary outcome [18] 0 0
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow
Timepoint [18] 0 0
Up to approximately 5 years
Secondary outcome [19] 0 0
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse Identified by Immunohistochemistry or Flow Cytometry for Cerebrospinal Fluid
Timepoint [19] 0 0
Up to end of safety follow up (approximately 44 months)
Secondary outcome [20] 0 0
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid
Timepoint [20] 0 0
Up to end of safety follow up (approximately 44 months)
Secondary outcome [21] 0 0
Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML)
Timepoint [21] 0 0
Up to end of safety follow up (approximately 44 months)
Secondary outcome [22] 0 0
Phase 3: Localization of Relapse by Clinical Assessment
Timepoint [22] 0 0
Up to end of safety follow up (approximately 44 months)
Secondary outcome [23] 0 0
Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR)
Timepoint [23] 0 0
Up to approximately 5 years
Secondary outcome [24] 0 0
Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR)
Timepoint [24] 0 0
Up to approximately 5 years
Secondary outcome [25] 0 0
Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Timepoint [25] 0 0
Up to approximately 5 years
Secondary outcome [26] 0 0
Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Timepoint [26] 0 0
Up to approximately 5 years
Secondary outcome [27] 0 0
Phase 3: Time to Deterioration using the Fatigue Score
Timepoint [27] 0 0
Up to approximately 5 years
Secondary outcome [28] 0 0
Phase 3: Time to Improvements using the Fatigue Score
Timepoint [28] 0 0
Up to approximately 5 years
Secondary outcome [29] 0 0
Phase 3: Time to Deterioration using the Pain Score
Timepoint [29] 0 0
Up to approximately 5 years
Secondary outcome [30] 0 0
Phase 3: Time to Improvements using the Pain Score
Timepoint [30] 0 0
Up to approximately 5 years
Secondary outcome [31] 0 0
Phase 3: Change from Baseline in Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [31] 0 0
Baseline to end of study (up to approximately 5 years)
Secondary outcome [32] 0 0
Phase 3: Time to Deterioration for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [32] 0 0
Up to approximately 5 years
Secondary outcome [33] 0 0
Phase 3: Time to Improvements for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [33] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
- Age = 55 years at the time of informed consent. OR

Age 40 to < 55 years of age if at least 1 of the following comorbidities at the time of informed consent:

* history of grades 3 and 4 pancreatitis
* diabetes mellitus with end-organ damage
* severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) > 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
* body mass index (BMI) = 40 combined with relevant comorbidities such as metabolic syndrome
* Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed. A medical advisory board is available to the investigators for questions/advice and includes experts in the field of adult leukemia with experience with the use of blinatumomab, the global development lead for blinatumomab and the medical monitor of the study.

* Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
* Eastern Cooperative Oncology Group (ECOG) performance status = 2, higher ECOG score allowed if due to underlying leukemia
* All participants must have adequate organ function as defined below:
* renal: estimated glomerular filtration rate based on MDRD calculation = 50 mL/min/1.73 m^2
* liver function: total bilirubin = 2x upper limit of normal (ULN; unless Gilbert's Disease or if liver involvement with leukemia); exception for participants 40 to < 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT > 10 x ULN (liver cirrhosis must be confirmed by biopsy)
* cardiac: left ventricular ejection fraction (LVEF) = 50%
Minimum age
40 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active central nervous system (CNS) leukemia not resolved with IT chemotherapy during screening.
* Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy).
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Known infection with human immunodeficiency virus (HIV)
* Known infection with chronic or active infection with hepatitis B (eg, hepatitis b surface [HBs] antigen reactive or quantifiable hepatitis b virus [HBV] viral load) or hepatitis C virus (HCV) (eg, HCV RNA [qualitative] is detected).

Active hepatitis B and C based on the following results:

* positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR result is necessary to enroll.
* positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR result is necessary to enroll.

* Participant with symptoms and/or clinical signs and/or radiographic and/or sonographic signs that indicate an acute or uncontrolled chronic infection.
* Cancer chemotherapy for this newly diagnosed B cell ALL before the start of protocol-required therapy with the exception of IT chemotherapy or pre-phase chemotherapy. Radiation to a spot lesion such as chloroma or lytic lesion of bone or vertebrae for pain or vertebral stabilization is allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 3
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
2/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2031
Actual
Sample size
Target
287
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Austin Health, Austin Hospital - Heidelberg
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [12] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3000 - Melbourne
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 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
Florida
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
South Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Austria
State/province [6] 0 0
Graz
Country [7] 0 0
Austria
State/province [7] 0 0
Innsbruck
Country [8] 0 0
Austria
State/province [8] 0 0
Linz
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Anderlecht
Country [11] 0 0
Belgium
State/province [11] 0 0
Brugge
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Ghent
Country [15] 0 0
Belgium
State/province [15] 0 0
Hasselt
Country [16] 0 0
Belgium
State/province [16] 0 0
Liege
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Belgium
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Roeselare
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Belgium
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Yvoir
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Brazil
State/province [19] 0 0
Rio Grande Do Sul
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Brazil
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São Paulo
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Bulgaria
State/province [21] 0 0
Plovdiv
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Bulgaria
State/province [22] 0 0
Sofia
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Canada
State/province [23] 0 0
Alberta
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Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Chile
State/province [29] 0 0
Santiago
Country [30] 0 0
Denmark
State/province [30] 0 0
Aalborg
Country [31] 0 0
Denmark
State/province [31] 0 0
Aarhus N
Country [32] 0 0
Denmark
State/province [32] 0 0
København Ø
Country [33] 0 0
Denmark
State/province [33] 0 0
Odense
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Finland
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Helsinki
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Finland
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Turku
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France
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Creteil
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France
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Dijon
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France
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Le Chesnay Cedex
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France
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Lille
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France
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Marseille
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France
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Nantes Cedex 1
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France
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Nice cedex 3
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France
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Paris
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France
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Pessac Cedex
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France
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Pierre Benite
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France
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Rennes Cedex 9
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France
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Toulouse cedex 9
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France
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Vandoeuvre les Nancy Cedex
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Duesseldorf
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Kiel
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Germany
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Muenchen
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Nyiregyhaza
Country [67] 0 0
Italy
State/province [67] 0 0
Bari
Country [68] 0 0
Italy
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Bergamo
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Italy
State/province [69] 0 0
Bologna
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Italy
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Genova
Country [71] 0 0
Italy
State/province [71] 0 0
Lecce
Country [72] 0 0
Italy
State/province [72] 0 0
Mestre (VE)
Country [73] 0 0
Italy
State/province [73] 0 0
Milano
Country [74] 0 0
Italy
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Napoli
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Italy
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Perugia
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Italy
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Pescara
Country [77] 0 0
Italy
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Roma
Country [78] 0 0
Italy
State/province [78] 0 0
Verona
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Japan
State/province [79] 0 0
Aichi
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Japan
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Akita
Country [81] 0 0
Japan
State/province [81] 0 0
Chiba
Country [82] 0 0
Japan
State/province [82] 0 0
Fukui
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Japan
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Fukuoka
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Japan
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Fukushima
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Japan
State/province [85] 0 0
Gunma
Country [86] 0 0
Japan
State/province [86] 0 0
Hokkaido
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Japan
State/province [87] 0 0
Hyogo
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Japan
State/province [88] 0 0
Ishikawa
Country [89] 0 0
Japan
State/province [89] 0 0
Kanagawa
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Japan
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Nagasaki
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Japan
State/province [91] 0 0
Okayama
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Japan
State/province [92] 0 0
Osaka
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Japan
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Tochigi
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Japan
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Yamagata
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Korea, Republic of
State/province [95] 0 0
Busan
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Korea, Republic of
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Hwasun
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Korea, Republic of
State/province [97] 0 0
Seoul
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Mexico
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Distrito Federal
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Mexico
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Nuevo León
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Mexico
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Huixquilucan
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Netherlands
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Groningen
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Portugal
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Coimbra
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Portugal
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Lisboa
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
State/province [106] 0 0
Iasi
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Romania
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Sibiu
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Spain
State/province [108] 0 0
Andalucía
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Spain
State/province [109] 0 0
Cantabria
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Spain
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Castilla León
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Spain
State/province [111] 0 0
Cataluña
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Spain
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Comunidad Valenciana
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Sweden
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Goteborg
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Switzerland
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Bern
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Taiwan
State/province [115] 0 0
Taichung
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Taiwan
State/province [116] 0 0
Tainan
Country [117] 0 0
Taiwan
State/province [117] 0 0
Taipei
Country [118] 0 0
Taiwan
State/province [118] 0 0
Taoyuan
Country [119] 0 0
Turkey
State/province [119] 0 0
Ankara
Country [120] 0 0
Turkey
State/province [120] 0 0
Istanbul
Country [121] 0 0
Turkey
State/province [121] 0 0
Izmir
Country [122] 0 0
Turkey
State/province [122] 0 0
Samsun
Country [123] 0 0
United Kingdom
State/province [123] 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
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

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: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04994717