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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
Date last updated
14/11/2024

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
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [9] 0 0
Austin Health, Austin Hospital - Heidelberg
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 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
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Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
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Ghent
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Belgium
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Hasselt
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Belgium
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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
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Rio Grande Do Sul
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Brazil
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São Paulo
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
Country [29] 0 0
Chile
State/province [29] 0 0
Santiago
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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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Creteil
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Dijon
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Lille
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Marseille
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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
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Genova
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Italy
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Lecce
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Italy
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Mestre (VE)
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Italy
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Milano
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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
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Italy
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Roma
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Italy
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Verona
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Japan
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Aichi
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Japan
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Akita
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Japan
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Chiba
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Japan
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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
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Gunma
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Nagasaki
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Japan
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Okayama
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Japan
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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
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Busan
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Korea, Republic of
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Hwasun
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Korea, Republic of
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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
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Iasi
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Romania
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Sibiu
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Spain
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Andalucía
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Spain
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Cantabria
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Spain
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Castilla León
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Spain
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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
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
Country [118] 0 0
Taiwan
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Taoyuan
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
State/province [122] 0 0
Samsun
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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
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT04994717
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04994717