Clinical Trials List
Protocol Number20190360
NCT Number(ClinicalTrials.gov Identfier)NCT04994717
2021-09-30 - 2030-04-04
Phase III
Recruiting5
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)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Amgen Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Wen-Chien Chou Division of General Internal Medicine
- Chien-Chin Lin Division of General Internal Medicine
- - - Division of General Internal Medicine
- Huai-Hsuan Huang Division of General Internal Medicine
- - - Division of General Internal Medicine
- Tai-Chung Huang Division of General Internal Medicine
- 田豐銘 Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Che-Hung Lin 無
- 鄭富銘 無
- Tzu-Ting Chen 無
- 王秀慈 無
- Ching-Chan Lin 無
- Ming-Hung Tsai 無
- 陳珈妤 無
- Ming-Yu Lien 無
- Chi-Ching Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HSUAN JEN SHIH 無
- 高小雯 無
- 王元欽 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Objectives
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.
Test Drug
BLINCYTO for Injection
Active Ingredient
Blinatumomab (AMG 103)
Dosage Form
lyophilized powder for reconstitution for injection
Dosage
38.5
Endpoints
Primary Outcome Measures :
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 5 years ]
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Phase 3: Event-free Survival (EFS) [ Time Frame: Up to approximately 5 years ]
Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier.
Treatment failure is defined as not achieving a hematological complete CR with MRD response <10-4 by the end of the initial disease assessment period.
Relapse is defined as hematologic relapse, extramedullary relapse, or molecular relapse (MRD positivity >= 10^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response <10^-4.
Participants without an event will be censored at their last evaluable disease assessment date.
Phase 3: Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
OS is defined as time from randomization (enrollment) until death due to any cause.
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 5 years ]
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Phase 3: Event-free Survival (EFS) [ Time Frame: Up to approximately 5 years ]
Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier.
Treatment failure is defined as not achieving a hematological complete CR with MRD response <10-4 by the end of the initial disease assessment period.
Relapse is defined as hematologic relapse, extramedullary relapse, or molecular relapse (MRD positivity >= 10^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response <10^-4.
Participants without an event will be censored at their last evaluable disease assessment date.
Phase 3: Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
OS is defined as time from randomization (enrollment) until death due to any cause.
Inclution Criteria
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%
- 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%
Exclusion Criteria
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.
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.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
274 participants
