Clinical Trials List
Protocol Number20190360
NCT Number(ClinicalTrials.gov Identfier)NCT04994717
Active
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
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 高小雯 無
- HSUAN JEN SHIH 無
- 王元欽 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王幸婷 無
- Ching-Chan Lin 無
- 陳珈妤 無
- Ming-Yu Lien 無
- 鄭富銘 無
- Che-Hung Lin 無
- Tzu-Ting Chen 無
- 王秀慈 無
- Chi-Ching Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄧齡喬 無
- CHENG-HSIEN LIN 無
- Chieh-Lin Teng Division of Hematology & Oncology
- PO-WEI LIAO 無
- HSIN-CHEN LIN 無
- PO-HSIEN LI 無
- ZHENG-WEI ZHOU 無
- 滕傑林 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 田豐銘 Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
- - - Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- - - Division of General Internal Medicine
- Chien-Chin Lin Division of General Internal Medicine
- Huai-Hsuan Huang Division of General Internal Medicine
- Wen-Chien Chou Division of General Internal Medicine
- Tai-Chung Huang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
- Ya-Ting Hsu Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Objectives
This randomized trial will evaluate whether a regimen of reduced-dose chemotherapy plus enhanced blinatumomab improves outcomes compared to two standard-of-care (SOC) trials (GMALL and hyperCVAD) in patients aged ≥ 55 years and a well-defined 40 to < 55 years with multiple comorbidities who are not suitable for pediatric-based treatment.
Taiwan will only participate in Phase 3.
Primary Objectives
• Compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy with that of subjects receiving standard-of-care (SOC) chemotherapy.
• Compare overall survival (OS) of blinatumomab alternating with low-intensity chemotherapy versus SOC chemotherapy.
Secondary Objectives
• Compare other efficacy endpoints of blinatumomab alternating with low-intensity chemotherapy versus SOC chemotherapy.
• Compare the safety of blinatumomab alternating with low-intensity chemotherapy versus SOC chemotherapy.
• Explore relapse characteristics in the two treatment groups, including differentiation cluster (CD) 19 presentation, lineage conversion, and relapse site.
• Assess relapse-free mortality in the two treatment groups.
• Assess the efficacy of allogeneic hematopoietic stem cell transplantation (all-in-care) compared to SOC chemotherapy after receiving blinatumomab alternating with low-intensity chemotherapy.
Test Drug
皮下注射劑
Active Ingredient
Blinatumomab (AMG 103)
Dosage Form
220
Dosage
38.5 mcg, vial
Endpoints
• Compare the event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy with the EFS of subjects receiving standard-of-care (SOC) chemotherapy.
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.
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% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.
- 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.
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% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.
Exclusion Criteria
Exclusion Criteria:
Active central nervous system (CNS) leukemia (i.e., CNS 3 leukemia, confirmed by lumbar puncture) not resolved with IT chemotherapy during screening.
History of other malignancy within the past 3 years, with the following exceptions:
Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Adequately treated breast ductal carcinoma in situ without evidence of disease
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
Clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric conditions that preclude the use of high dose of corticosteroids
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 central nervous system (CNS) leukemia (i.e., CNS 3 leukemia, confirmed by lumbar puncture) not resolved with IT chemotherapy during screening.
History of other malignancy within the past 3 years, with the following exceptions:
Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Adequately treated breast ductal carcinoma in situ without evidence of disease
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
Clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric conditions that preclude the use of high dose of corticosteroids
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).
The Estimated Number of Participants
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Taiwan
12 participants
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Global
314 participants
