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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

Primary Purpose

Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blinatumomab
Low-intensity chemotherapy regimen
SOC chemotherapy regimen
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) focused on measuring Newly Diagnosed Philadelphia (Ph)-negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), Blinatumomab, Low-intensity Chemotherapy, GMALL HyperCVAD

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

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.

Sites / Locations

  • City of Hope National Medical CenterRecruiting
  • University of California IrvineRecruiting
  • University of California San Francisco Medical CenterRecruiting
  • AdventHealth OrlandoRecruiting
  • Saint Francis Hospital, IncRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • FundaleuRecruiting
  • Royal North Shore HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • The Alfred HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • Medizinische Universitaet GrazRecruiting
  • Hanusch KrankenhausRecruiting
  • AZ Sint-Jan Brugge-Oostende AVRecruiting
  • Universite Catholique de Louvain Cliniques Universitaires Saint LucRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
  • AZ Delta Campus RumbekeRecruiting
  • Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain NamurRecruiting
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EADRecruiting
  • Specialized Hospital for Active Treatment of Hematology Diseases EADRecruiting
  • Aarhus UniversitetshospitalRecruiting
  • Odense UniversitetshospitalRecruiting
  • Hôpital Henri MondorRecruiting
  • Centre Hospitalier Universitaire de Nantes - Hopital Hotel DieuRecruiting
  • Centre Hospitalier Universitaire Archet 2Recruiting
  • Hôpital Saint LouisRecruiting
  • Hopital Saint AntoineRecruiting
  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut LevequeRecruiting
  • Hopital Lyon SudRecruiting
  • Klinikum AugsburgRecruiting
  • Charite - Universitaetsmedizin Berlin, Campus Benjamin FranklinRecruiting
  • Universitaetsklinikum DresdenRecruiting
  • Universitätsklinikum DüsseldorfRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Universitaetsklinikum JenaRecruiting
  • Universitaetsklinikum Schleswig-HolsteinRecruiting
  • Klinikum der LMU MuenchenRecruiting
  • Evangelismos HospitalRecruiting
  • Laiko General Hospital of AthensRecruiting
  • Attiko General University HospitalRecruiting
  • University Hospital of PatrasRecruiting
  • General Hospital of Thessaloniki Georgios PapanikolaouRecruiting
  • Semmelweis EgyetemRecruiting
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai IntezetRecruiting
  • Heves Varmegyei Markhot Ferenc Oktatokorhaz es RendelointezetRecruiting
  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras TagkorhazRecruiting
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecruiting
  • Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola MalpighiRecruiting
  • Ospedale Policlinico San Martino IRCCSRecruiting
  • Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell AngeloRecruiting
  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della MisericordiaRecruiting
  • Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo SpiritoRecruiting
  • Nagoya University HospitalRecruiting
  • Akita University HospitalRecruiting
  • University of Fukui HospitalRecruiting
  • Kyushu University HospitalRecruiting
  • Kurume University HospitalRecruiting
  • Fukushima Medical University HospitalRecruiting
  • Sapporo Hokuyu HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Nagasaki University HospitalRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Jichi Medical University HospitalRecruiting
  • Yamagata University HospitalRecruiting
  • Centro Hospitalar Universitario de Lisboa Central, EPE - Hospital de Santo Antonio dos CapuchosRecruiting
  • Institutul Clinic FundeniRecruiting
  • Institutul Oncologic Prof Dr Ion ChiricutaRecruiting
  • Institutul Regional de Oncologie IasiRecruiting
  • Spitalul Clinic Judetean de Urgenta SibiuRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitari Vall d HebronRecruiting
  • Institut Catala d Oncologia Hospitalet Hospital Duran i ReynalsRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Hacettepe Universitesi Tip FakultesiRecruiting
  • Bagcilar Medipol Mega Universite HastanesiRecruiting
  • Dokuz Eylul Universitesi Onkoloji EnstitusuRecruiting
  • Ondokuz Mayis Universitesi Tip FakultesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy

Phase 3: Blinatumomab alternating with low-intensity chemotherapy

Phase 3: Standard of care (SOC) chemotherapy

Arm Description

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.

Participants will receive blinatumomab alternating with low-intensity chemotherapy.

Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.

Outcomes

Primary Outcome Measures

Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
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 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, and/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)
OS is defined as time from randomization (enrollment) until death due to any cause.

Secondary Outcome Measures

Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
MRD response is defined as the percentage of participants who achieve a response of < 10^-4 measured by polymerase chain reaction (PCR).
Safety run-in: Relapse-free Survival (RFS)
RFS: In participants who achieve CR, the time from first achievement of this response until date of the first relapse including hematologic relapse, extramedullary relapse, or death due to any cause, whichever occurs first.
Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
MRD RFS: In participants who achieve CR with MRD response, the time from first achievement of this response until date of of the first relapse including molecular relapse, hematological relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. (Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>=10^-4. Participants without an event will be censored at their last evaluable disease assessment date.
Safety run-in: Steady State Concentration (Css) of Blinatumomab
Safety run-in: Clearance (CL) of Blinatumomab
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score
Fatigue score will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a.
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score
Pain score will be measured by Brief Pain Inventory - Short Form (BPI-SF); Item 3: pain at its worst in the last 24 hours.
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status
Global health status will be measured by the Quality of Life Questionnaire (QLQ)-C30 global health status quality of life scale.
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function
Physical function will be measured by the QLQ-C30 functional scale.
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting
Nausea and vomiting will be measured by the QLQ-C30 symptom scale.
Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
MRD response is defined as the percentage of participants who achieve a response of < 10^4 measured by polymerase chain reaction (PCR).
Phase 3: Relapse-free Survival (RFS)
RFS: In participants who achieve CR, the time from first achievement of this response until the date of the first relapse including hematologic relapse, extra medullary relapse, or death due to any cause, whichever occurs first. Participants without an event will be censored at their last evaluable disease assessment date.
Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
In participants who achieve CR with MRD response, the time from first achievement of this response until date of the first relapse including molecular relapse, hematologic relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>= 10^-4. Participants without an event will be censored at their last evaluable disease assessment date
Phase 3: Minimal Residual Disease (MRD) Over Time
Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow
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
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid
Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML)
Phase 3: Localization of Relapse by Clinical Assessment
Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR)
Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR)
Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Phase 3: Time to Deterioration using the Fatigue Score
Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
Phase 3: Time to Improvements using the Fatigue Score
Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
Phase 3: Time to Deterioration using the Pain Score
Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
Phase 3: Time to Improvements using the Pain Score
Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
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)
EORTC QLQ-C30 will include global health status, physical functioning, emotional functioning, cognitive functioning, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QLQ-C30.
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)
Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.
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)
Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.

Full Information

First Posted
July 30, 2021
Last Updated
October 12, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04994717
Brief 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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
July 8, 2026 (Anticipated)
Study Completion Date
April 9, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Keywords
Newly Diagnosed Philadelphia (Ph)-negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), Blinatumomab, Low-intensity Chemotherapy, GMALL HyperCVAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 3: Blinatumomab alternating with low-intensity chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive blinatumomab alternating with low-intensity chemotherapy.
Arm Title
Phase 3: Standard of care (SOC) chemotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
Blincyto®
Intervention Description
Continuous intravenous (cIV) infusion
Intervention Type
Drug
Intervention Name(s)
Low-intensity chemotherapy regimen
Intervention Description
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Intervention Type
Drug
Intervention Name(s)
SOC chemotherapy regimen
Intervention Description
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Primary Outcome Measure Information:
Title
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Description
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Time Frame
Up to approximately 5 years
Title
Phase 3: Event-free Survival (EFS)
Description
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, and/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.
Time Frame
Up to approximately 5 years
Title
Phase 3: Overall Survival (OS)
Description
OS is defined as time from randomization (enrollment) until death due to any cause.
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Time Frame
Baseline to Week 14
Title
Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
Description
MRD response is defined as the percentage of participants who achieve a response of < 10^-4 measured by polymerase chain reaction (PCR).
Time Frame
Baseline to Week 14
Title
Safety run-in: Relapse-free Survival (RFS)
Description
RFS: In participants who achieve CR, the time from first achievement of this response until date of the first relapse including hematologic relapse, extramedullary relapse, or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 5 years
Title
Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
Description
MRD RFS: In participants who achieve CR with MRD response, the time from first achievement of this response until date of of the first relapse including molecular relapse, hematological relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. (Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>=10^-4. Participants without an event will be censored at their last evaluable disease assessment date.
Time Frame
Up to approximately 5 years
Title
Safety run-in: Steady State Concentration (Css) of Blinatumomab
Time Frame
Up to approximately 34 weeks
Title
Safety run-in: Clearance (CL) of Blinatumomab
Time Frame
Up to approximately 34 weeks
Title
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score
Description
Fatigue score will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a.
Time Frame
Baseline to Week 14
Title
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score
Description
Pain score will be measured by Brief Pain Inventory - Short Form (BPI-SF); Item 3: pain at its worst in the last 24 hours.
Time Frame
Baseline to Week 14
Title
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status
Description
Global health status will be measured by the Quality of Life Questionnaire (QLQ)-C30 global health status quality of life scale.
Time Frame
Baseline to Week 14
Title
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function
Description
Physical function will be measured by the QLQ-C30 functional scale.
Time Frame
Baseline to Week 14
Title
Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting
Description
Nausea and vomiting will be measured by the QLQ-C30 symptom scale.
Time Frame
Baseline to Week 14
Title
Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Time Frame
Baseline to Week 14
Title
Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
Description
MRD response is defined as the percentage of participants who achieve a response of < 10^4 measured by polymerase chain reaction (PCR).
Time Frame
Baseline to Week 14
Title
Phase 3: Relapse-free Survival (RFS)
Description
RFS: In participants who achieve CR, the time from first achievement of this response until the date of the first relapse including hematologic relapse, extra medullary relapse, or death due to any cause, whichever occurs first. Participants without an event will be censored at their last evaluable disease assessment date.
Time Frame
Up to approximately 5 years
Title
Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
Description
In participants who achieve CR with MRD response, the time from first achievement of this response until date of the first relapse including molecular relapse, hematologic relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>= 10^-4. Participants without an event will be censored at their last evaluable disease assessment date
Time Frame
Up to approximately 5 years
Title
Phase 3: Minimal Residual Disease (MRD) Over Time
Time Frame
Up to approximately 5 years
Title
Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Description
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Time Frame
Up to approximately 5 years
Title
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow
Time Frame
Up to approximately 5 years
Title
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
Time Frame
Up to end of safety follow up (approximately 44 months)
Title
Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid
Time Frame
Up to end of safety follow up (approximately 44 months)
Title
Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML)
Time Frame
Up to end of safety follow up (approximately 44 months)
Title
Phase 3: Localization of Relapse by Clinical Assessment
Time Frame
Up to end of safety follow up (approximately 44 months)
Title
Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR)
Time Frame
Up to approximately 5 years
Title
Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR)
Time Frame
Up to approximately 5 years
Title
Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Time Frame
Up to approximately 5 years
Title
Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Time Frame
Up to approximately 5 years
Title
Phase 3: Time to Deterioration using the Fatigue Score
Description
Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
Time Frame
Up to approximately 5 years
Title
Phase 3: Time to Improvements using the Fatigue Score
Description
Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.
Time Frame
Up to approximately 5 years
Title
Phase 3: Time to Deterioration using the Pain Score
Description
Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
Time Frame
Up to approximately 5 years
Title
Phase 3: Time to Improvements using the Pain Score
Description
Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.
Time Frame
Up to approximately 5 years
Title
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)
Description
EORTC QLQ-C30 will include global health status, physical functioning, emotional functioning, cognitive functioning, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QLQ-C30.
Time Frame
Baseline to end of study (up to approximately 5 years)
Title
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)
Description
Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.
Time Frame
Up to approximately 5 years
Title
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)
Description
Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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% 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Francis Hospital, Inc
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Fundaleu
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1114
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hanusch Krankenhaus
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta Campus Rumbeke
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
City
Plovdiv
ZIP/Postal Code
40002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Hematology Diseases EAD
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Aarhus Universitetshospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Archet 2
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69645
Country
France
Individual Site Status
Recruiting
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der LMU Muenchen
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evangelismos Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attiko General University Hospital
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Thessaloniki Georgios Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Policlinico San Martino IRCCS
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
City
Mestre (VE)
ZIP/Postal Code
30174
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Akita University Hospital
City
Akita-shi
State/Province
Akita
ZIP/Postal Code
010-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Fukui Hospital
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Hokuyu Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Oncologic Prof Dr Ion Chiricuta
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
City
Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bagcilar Medipol Mega Universite Hastanesi
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul Universitesi Onkoloji Enstitusu
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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